Farkon LAG-3-Tsarin hanawar rigakafin jiki, Opdualag ™ (nivolumab da relatlimab-rmbw), FDA ta amince da su ga marasa lafiya da ke da melanoma da ba a sake su ba.

Afrilu 2022: Hukumar Abinci da Magunguna ta Amurka (FDA) ta amince Opdualag (nivolumab da relatlimab-rmbw), wani sabon, na farko-in-aji ƙayyadaddun ƙayyadaddun kashi na nivolumab da relatlimab da aka gudanar a matsayin jiko guda ɗaya na jiko, don kula da manya da yara marasa lafiya 12 shekaru da haihuwa tare da unresectable ko metastatic melanoma. Amincewar ta dogara ne akan binciken SAURARA-047 Phase 2/3, wanda ya kwatanta Opdualag (n=355) zuwa nivolumab kadai (n=359) a cikin yawan marasa lafiya na 355.

Gwajin ya gamu da matakin ƙarshe na farko, rayuwa marar ci gaba (PFS), da Opdualag fiye da ninki biyu na matsakaicin PFS idan aka kwatanta da nivolumab monotherapy, watanni 10.1 (95% Tsakanin Amincewa [CI]: 6.4 zuwa 15.7) tare da watanni 4.6 (95% CI: 3.4 zuwa 5.6); (Hazard Ratio [HR] 0.75; 95% CI: 0.62 zuwa 0.92, P= 0.0055).¹ The Opdualag bayanin martabar aminci yayi kama da wanda aka ruwaito a baya na nivolumab.^1,2 Ba a gano sababbin abubuwan da suka faru na aminci tare da haɗin gwiwa ba idan aka kwatanta da nivolumab monotherapy.^1,2 Matsalolin 3/4 marasa illa masu alaƙa da ƙwayoyi sun kasance 18.9% a cikin Opdualag hannu idan aka kwatanta da 9.7% a hannun nivolumab.² Abubuwan da suka shafi miyagun ƙwayoyi da ke haifar da dakatarwa sun kasance 14.6% a cikin Opdualag hannu idan aka kwatanta da 6.7% a hannun nivolumab.²

"Tun lokacin da aka amince da mai hanawa na farko na rigakafi fiye da shekaru 10 da suka wuce, mun ga maganin rigakafi, kadai kuma a hade, ya canza maganin marasa lafiya tare da ci gaba da cutar melanoma," in ji F. Stephen Hodi, MD, darektan Cibiyar Melanoma. da Cibiyar Immuno-Oncology a Cibiyar Ciwon daji ta Dana-Farber.³ “Yin amincewar yau yana da mahimmanci musamman, kamar yadda yake yana gabatar da sabon haɗin gwiwa na rigakafi guda biyu waɗanda zasu iya aiki tare don taimakawa haɓaka amsawar rigakafin cutar ta hanyar yin niyya ta wuraren bincike daban-daban guda biyu - LAG-3 da PD-1. ”^1,2

Opdualag yana da alaƙa da Gargaɗi & Rigakafi masu zuwa: mai tsanani da kuma m rigakafi-matsakaici m halayen (IMARs) ciki har da pneumonitis, colitis, hepatitis, endocrinopathy, nephritis tare da renal tabarbarewar, dermatologic m halayen, myocarditis da sauran rigakafi-mediated m halayen; halayen da suka danganci jiko; rikitarwa na allogeneic hematopoietic stem cell transplantation (HSCT); da embryo-fetal toxicity.¹ Da fatan za a duba Muhimman Bayanan Tsaro a ƙasa.

"Yayin da muka sami babban ci gaba a cikin maganin cutar melanoma mai ci gaba a cikin shekaru goma da suka gabata, mun himmatu wajen fadada hanyoyin maganin rigakafi guda biyu ga wadannan marasa lafiya," in ji Samit Hirawat, babban jami'in kula da lafiya, ci gaban magunguna na duniya, Bristol Myers Squibb.³ "Hana LAG-3 tare da relatlimab, a cikin ƙayyadaddun tsari tare da nivolumab, yana wakiltar sabon tsarin kulawa wanda ya gina kan gadonmu na kawo sabbin hanyoyin rigakafin rigakafi ga marasa lafiya. Yarda da wani sabon magani wanda ya haɗa da mai hana binciken mu na uku yana nuna muhimmin mataki na gaba wajen baiwa marasa lafiya ƙarin zaɓuɓɓuka fiye da maganin monotherapy. "

Lymphocyte activation gene-3 (LAG-3) da kuma shirin mutuwa-1 (PD-1) sune wuraren bincike na rigakafi guda biyu daban-daban waɗanda galibi ana bayyana su akan ƙwayoyin lymphocytes masu kamuwa da ƙari, don haka suna ba da gudummawa ga gajiyawar T-cell mai matsakaici.² Haɗin nivolumab (anti-PD-1) da relatlimab (anti-LAG-3) yana haifar da ƙara yawan kunnawa T-cell idan aka kwatanta da aikin ko dai antibody kadai.¹ Relatlimab (a hade tare da nivolumab) shine farkon LAG-3-karewa antibody don nuna fa'ida a cikin binciken Phase 3.¹ Shi ne mai hanawa na uku (tare da anti-PD-1 da anti-CTLA-4) don Bristol Myers Squibb.

“Yin amincewar yau labari ne mai daɗi kuma yana ba da sabon bege ga al’ummar melanoma. Samuwar wannan haɗin gwiwar jiyya na iya baiwa marasa lafiya damar samun fa'ida daga sabon, ajin farko-in-aji dual immunotherapy, "in ji Michael Kaplan, shugaba da Shugaba, Melanoma Research Alliance.

Dosing ɗin da FDA ta amince da shi ga manya marasa lafiya da marasa lafiya na yara masu shekaru 12 ko sama da haka waɗanda suka auna aƙalla kilogiram 40 shine 480 MG nivolumab da 160 mg relatlimab ana gudanarwa ta cikin jini kowane mako huɗu.¹ Ba a kafa adadin shawarar da aka ba da shawarar ga marasa lafiya na yara masu shekaru 12 ko sama da su waɗanda nauyinsu bai wuce kilogiram 40 ba, da marasa lafiyar yara waɗanda ba su wuce shekaru 12 ba.¹

An amince da wannan aikace-aikacen a ƙarƙashin shirin matukin jirgi na Real-Time Oncology Review (RTOR), wanda ke da nufin tabbatar da cewa ana samun amintattun jiyya masu inganci ga marasa lafiya da wuri-wuri.⁴ An kuma gudanar da bitar a ƙarƙashin shirin FDA na Project Orbis, wanda ya ba da damar yin bita a lokaci guda daga hukumomin kiwon lafiya a Australia, Brazil da Switzerland, inda aikace-aikacen ke ci gaba da yin nazari.

Game da ZALUNCI-047

RELATIVITY-047 nazari ne na duniya, bazuwar, makafi biyu na Phase 2/3 wanda ke kimanta ƙayyadaddun haɗin haɗin nivolumab da relatlimab tare da nivolumab kaɗai a cikin marasa lafiya tare da melanoma da ba a kula da su a baya ba.^1,2 Gwajin ya keɓe marasa lafiya masu fama da cutar autoimmune mai aiki, yanayin kiwon lafiya da ke buƙatar magani na tsari tare da matsakaici ko babban adadin corticosteroids ko magungunan rigakafi, uveal melanoma, da kwakwalwa mai aiki ko marasa magani ko metastases na leptomeningeal.¹ Babban maƙasudin ƙarshen gwaji shine rayuwa marar ci gaba (PFS) wanda Makafi Independent Central Review (BICR) ya ƙaddara ta yin amfani da Ma'aunin Ƙimar Amsa a cikin Tumors (RECIST v1.1).¹ Ƙarshen ƙarshe na biyu shine gaba ɗaya rayuwa (OS) da ƙimar amsa haƙiƙa (ORR).¹ Jimillar marasa lafiya na 714 sun kasance bazuwar 1: 1 don karɓar ƙayyadaddun ƙayyadaddun adadin nivolumab (480 MG) da relatlimab (160 MG) ko nivolumab (480 MG) ta hanyar jiko na ciki kowane mako hudu har sai cutar ta ci gaba ko kuma rashin yarda da guba.¹

Zaɓi Bayanan Tsaro Daga ZARAFI-047

Mummunan halayen da ke haifar da dakatarwar dindindin na Opdualag ya faru a cikin 18% na marasa lafiya.¹Opdualag an katse shi saboda mummunan sakamako a cikin 43% na marasa lafiya.¹ Mummunan halayen haɗari sun faru a cikin 36% na marasa lafiya da aka yi musu magani Opdualag.¹ Mafi akai-akai (≥1%) mummunan halayen halayen su ne rashin ƙarfi na adrenal (1.4%), anemia (1.4%), colitis (1.4%), ciwon huhu (1.4%), myocardial infarction (1.1%), ciwon baya (1.1%). ), gudawa (1.1%), myocarditis (1.1%), da ciwon huhu (1.1%).¹ Mummunan halayen haɗari sun faru a cikin marasa lafiya uku (0.8%) da aka yi musu magani Opdualag kuma sun hada da hemophagocytic lymphohistiocytosis, m edema na huhu, da kuma pneumonitis.¹ Mafi na kowa (≥20%) mummunan halayen sune ciwon musculoskeletal (45%), gajiya (39%), rash (28%), pruritus (25%), da zawo (24%).¹ The Opdualag bayanin martabar aminci yayi kama da wanda aka ruwaito a baya na nivolumab.^1,2 Ba a gano sababbin abubuwan da suka faru na aminci tare da haɗin gwiwa ba idan aka kwatanta da nivolumab monotherapy.^1,2 Matsalolin 3/4 marasa illa masu alaƙa da ƙwayoyi sun kasance 18.9% a cikin Opdualag hannu idan aka kwatanta da 9.7% a hannun nivolumab.² Abubuwan da suka shafi miyagun ƙwayoyi da ke haifar da dakatarwa sun kasance 14.6% a cikin Opdualag hannu idan aka kwatanta da 6.7% a hannun nivolumab.²

Game da Melanoma

Melanoma wani nau'i ne na ciwon daji na fata wanda ke nuna rashin kulawa da girma na sel masu samar da launi (melanocytes) da ke cikin fata.⁵ Metastatic melanoma shine nau'in cutar mafi muni kuma yana faruwa lokacin da ciwon daji ya yadu sama da saman fata zuwa wasu gabobin.^5,6 Yawan cutar melanoma yana karuwa akai-akai tsawon shekaru 30 da suka gabata.^5,6 A cikin Amurka, an kiyasta kusan 99,780 sabbin cututtukan cutar melanoma da kusan mutuwar 7,650 masu alaƙa don 2022.⁵ Melanoma na iya zama galibi ana samun magani idan an kama shi a farkon matakansa; duk da haka, adadin tsira na iya raguwa yayin da cutar ke ci gaba.⁶

Alamar OPDUALAG

Opdualag ^TM (nivolumab da relatlimab-rmbw) ana nuna su don kula da manya da marasa lafiya na yara masu shekaru 12 ko sama da haka tare da melanoma wanda ba a iya gyarawa ko metastatic.

OPDUALAG MUHIMMAN BAYANIN TSIRA

Mummunan Maganganun Magani-Mai Mutuwar Kariya

Abubuwan da ba su dace ba na garkuwar jiki (IMARs) da aka jera a nan na iya haɗawa da duk wani mummunan sakamako na tsaka-tsakin rigakafi mai yiwuwa.

IMARs wanda zai iya zama mai tsanani ko mai kisa, na iya faruwa a kowace gabobin jiki ko nama. IMARs na iya faruwa a kowane lokaci bayan fara jiyya tare da LAG-3 da PD-1/PD-L1 masu hana ƙwayoyin cuta. Duk da yake IMARs yawanci suna bayyana yayin jiyya, kuma suna iya faruwa bayan katsewar Opdualag. Ganewar farko da sarrafa IMARs suna da mahimmanci don tabbatar da amfani mai aminci. Kula da marasa lafiya a hankali don alamun alamun da alamun da zasu iya zama bayyanar asibiti na IMARs na asali. Yi la'akari da sunadarai na asibiti ciki har da enzymes hanta, creatinine, da aikin thyroid a asali da lokaci-lokaci yayin jiyya. A cikin abubuwan da ake zargin IMARs, fara aikin da ya dace don keɓance madadin abubuwan da suka haɗa da kamuwa da cuta. Cibiyar kula da lafiya cikin gaggawa, gami da shawarwari na musamman kamar yadda ya dace.

Riƙe ko dakatar da Opdualag na dindindin dangane da tsananin (da fatan za a duba sashe na 2 Sashi da Gudanarwa a cikin Cikakken Bayanin Rubuce-rubucen da ke rakiyar). Gabaɗaya, idan Opdualag yana buƙatar katsewa ko dakatarwa, gudanar da tsarin maganin corticosteroid (1 zuwa 2 mg / kg / day prednisone ko daidai) har sai an inganta zuwa Grade 1 ko ƙasa da haka. Bayan haɓaka zuwa digiri na 1 ko ƙasa da haka, fara corticosteroid taper kuma ci gaba da yin taper sama da akalla wata 1. Yi la'akari da gudanar da wasu magungunan rigakafi na tsarin a cikin marasa lafiya waɗanda ba a sarrafa IMARs tare da maganin corticosteroid. Jagororin sarrafa guba don mummunan halayen da ba dole ba ne ya buƙaci magungunan ƙwayoyin cuta (misali, endocrinopathy da halayen dermatologic) an tattauna su a ƙasa.

Pneumonitis na rigakafi-Mediated

Opdualag na iya haifar da pneumonitis mai shiga tsakani, wanda zai iya zama m. A cikin marasa lafiya da aka bi da su tare da wasu PD-1/PD-L1 masu hana ƙwayoyin cuta, yawan ciwon pneumonitis ya fi girma a cikin marasa lafiya da suka karbi radiation na thoracic kafin. Pneumonitis mai tsaka-tsakin rigakafi ya faru a cikin 3.7% (13/355) na marasa lafiya da ke karɓar Opdualag, gami da Grade 3 (0.6%), da Grade 2 (2.3%) mummunan halayen. Pneumonitis ya haifar da dakatarwar Opdualag na dindindin a cikin 0.8% da kuma riƙe Opdualag a cikin 1.4% na marasa lafiya.

Colitis na rigakafi-Mediated

Opdualag na iya haifar da colitis mai tsaka-tsaki na rigakafi, wanda aka ayyana azaman buƙatar yin amfani da corticosteroids kuma babu bayyananniyar ilimin etiology. Alamar gama gari da aka haɗa a cikin ma'anar colitis shine gudawa. An ba da rahoton kamuwa da cutar cytomegalovirus / sake kunnawa a cikin marasa lafiya tare da corticosteroid-refractory immune-mediated colitis. A lokuta na corticosteroid-refractory colitis, yi la'akari da maimaita aikin motsa jiki don keɓance hanyoyin da za a iya amfani da su.

Zawo mai tsaka-tsakin rigakafi ko colitis ya faru a cikin 7% (24/355) na marasa lafiya da ke karɓar Opdualag, gami da Grade 3 (1.1%) da Grade 2 (4.5%) mummunan halayen. Colitis ya haifar da dakatarwar Opdualag na dindindin a cikin 2% da kuma riƙe Opdualag a cikin 2.8% na marasa lafiya.

Hepatitis Mai Magance Kariya

Opdualag na iya haifar da ciwon hanta mai shiga tsakani na rigakafi, wanda aka ayyana azaman buƙatar amfani da corticosteroids kuma babu wani takamaiman takamaiman ilimin etiology.

Hepatitis mai tsaka-tsakin rigakafi ya faru a cikin 6% (20/355) na marasa lafiya da ke karɓar Opdualag, gami da Grade 4 (0.6%), Grade 3 (3.4%), da Grade 2 (1.4%) mummunan halayen. Hepatitis ya haifar da dakatarwar Opdualag na dindindin a cikin 1.7% da kuma hana Opdualag a cikin 2.3% na marasa lafiya.

Endocrinopathy na rigakafi-Mediated

Opdualag na iya haifar da gazawar adrenal na farko ko na biyu, hypophysitis, cututtukan thyroid, da nau'in ciwon sukari na 1, wanda zai iya kasancewa tare da ketoacidosis na ciwon sukari. Riƙe ko dakatar da Opdualag na dindindin dangane da tsananin (da fatan za a duba sashe na 2 Sashi da Gudanarwa a cikin Cikakken Bayanin Rubuce-rubucen da ke rakiyar).

Don digiri na 2 ko mafi girma na rashin wadatar adrenal, fara maganin alamun bayyanar cututtuka, gami da maye gurbin hormone kamar yadda aka nuna a asibiti. A cikin marasa lafiya da ke karɓar Opdualag, ƙarancin adrenal ya faru a cikin 4.2% (15/355) na marasa lafiya da ke karɓar Opdualag, gami da Grade 3 (1.4%) da Grade 2 (2.5%) mummunan halayen. Rashin isasshen adrenal ya haifar da dakatarwar Opdualag na dindindin a cikin 1.1% da kuma hana Opdualag a cikin 0.8% na marasa lafiya.

Hypophysitis na iya gabatar da tare da m bayyanar cututtuka da ke hade da sakamako mai yawa kamar ciwon kai, photophobia, ko lahani na filin gani. Hypophysitis na iya haifar da hypopituitarism; fara maye gurbin hormone kamar yadda aka nuna a asibiti. Hypophysitis ya faru a cikin 2.5% (9/355) na marasa lafiya da ke karɓar Opdualag, gami da Grade 3 (0.3%) da Grade 2 (1.4%) mummunan halayen. Hypophysitis ya haifar da dakatarwar Opdualag na dindindin a cikin 0.3% da hana Opdualag a cikin 0.6% na marasa lafiya.

Thyroiditis na iya faruwa tare da ko ba tare da endocrinopathy ba. Hypothyroidism na iya bin hyperthyroidism; fara maye gurbin hormone ko kulawar likita kamar yadda aka nuna a asibiti. Thyroiditis ya faru a cikin 2.8% (10/355) na marasa lafiya da ke karɓar Opdualag, gami da halayen mara kyau na Grade 2 (1.1%). Thyroiditis bai haifar da dakatarwar Opdualag na dindindin ba. Thyroiditis ya haifar da hana Opdualag a cikin 0.3% na marasa lafiya. Hyperthyroidism ya faru a cikin 6% (22/355) na marasa lafiya da ke karɓar Opdualag, gami da Grade 2 (1.4%) mummunan halayen. Hyperthyroidism bai haifar da dakatarwar Opdualag na dindindin ba. Hyperthyroidism ya haifar da hana Opdualag a cikin 0.3% na marasa lafiya. Hypothyroidism ya faru a cikin 17% (59/355) na marasa lafiya da ke karɓar Opdualag, gami da halayen 2 (11%) mara kyau. Hypothyroidism ya haifar da dakatarwar Opdualag na dindindin a cikin 0.3% da kuma hana Opdualag a cikin 2.5% na marasa lafiya.

Kula da marasa lafiya don hyperglycemia ko wasu alamu da alamun ciwon sukari; fara jiyya tare da insulin kamar yadda aka nuna a asibiti. Ciwon sukari ya faru a cikin 0.3% (1/355) na marasa lafiya da ke karɓar Opdualag, wani mummunan sakamako na Grade 3 (0.3%), kuma babu lokuta na ketoacidosis masu ciwon sukari. Ciwon sukari bai haifar da katsewa na dindindin ko riƙe Opdualag a cikin kowane majiyyaci ba.

Nephritis na rigakafi-Mediated tare da rashin aikin Renal

Opdualag na iya haifar da nephritis mai tsaka-tsaki na rigakafi, wanda aka ayyana azaman buƙatar amfani da steroids kuma babu bayyananniyar etiology. A cikin marasa lafiya da ke karɓar Opdualag, nephritis mai tsaka-tsaki na rigakafi da rashin aikin koda ya faru a cikin 2% (7/355) na marasa lafiya, gami da Grade 3 (1.1%) da Grade 2 (0.8%) mummunan halayen. Nephritis mai tsaka-tsakin rigakafi da rashin aikin koda ya haifar da dakatarwar Opdualag na dindindin a cikin 0.8% da kuma riƙe Opdualag a cikin 0.6% na marasa lafiya.

Riƙe ko dakatar da Opdualag na dindindin dangane da tsananin (da fatan za a duba sashe na 2 Sashi da Gudanarwa a cikin Cikakken Bayanin Rubuce-rubucen da ke rakiyar).

Maganganun Cututtuka Masu Magance Cutar Kwayoyin cuta

Opdualag na iya haifar da kurji mai tsaka-tsaki na rigakafi ko dermatitis, wanda aka ayyana azaman buƙatar amfani da steroids kuma babu wani takamaiman yanayin yanayin. Exfoliative dermatitis, ciki har da Stevens-Johnson ciwo, mai guba epidermal necrolysis, da Drug Rash tare da eosinophilia da tsarin bayyanar cututtuka sun faru tare da PD-1 / L-1 toshe ƙwayoyin cuta. Abubuwan da ke motsa jiki da/ko corticosteroids na sama na iya zama isassu don magance rashes masu laushi zuwa matsakaici marasa exfoliative.

Riƙe ko dakatar da Opdualag na dindindin dangane da tsananin (da fatan za a duba sashe na 2 Sashi da Gudanarwa a cikin Cikakken Bayanin Rubuce-rubucen da ke rakiyar).

Ragewar rigakafin rigakafi ya faru a cikin 9% (33/355) na marasa lafiya, gami da Grade 3 (0.6%) da Grade 2 (3.4%) mummunan halayen. Ragewar rigakafin rigakafi bai haifar da dakatar da Opdualag na dindindin ba. Ragewar rigakafin rigakafi ya haifar da riƙe Opdualag a cikin 1.4% na marasa lafiya.

Myocarditis na rigakafi-Mediated

Opdualag na iya haifar da myocarditis mai tsaka-tsaki na rigakafi, wanda aka ayyana a matsayin buƙatar amfani da steroids kuma babu bayyananniyar ilimin etiology. Gano ganewar asali na myocarditis na rigakafi yana buƙatar babban ƙididdiga na zato. Ya kamata a tantance marasa lafiya da ke da alamun cututtukan zuciya ko na huhu don yiwuwar myocarditis. Idan ana zargin myocarditis, riƙe kashi, da sauri fara babban kashi na steroids (prednisone ko methylprednisolone 1 zuwa 2 mg/kg/rana) da sauri shirya shawarwarin zuciya tare da aikin bincike. Idan an tabbatar da asibiti, dakatar da Opdualag na har abada don Grade 2-4 myocarditis.

Myocarditis ya faru a cikin 1.7% (6/355) na marasa lafiya da ke karɓar Opdualag, gami da Grade 3 (0.6%), da Grade 2 (1.1%) mummunan halayen. Myocarditis ya haifar da dakatarwar Opdualag na dindindin a cikin 1.7% na marasa lafiya.

Sauran Maganganun Magance Magance Rigakafin Kariya

Wadannan IMARs masu mahimmanci na asibiti sun faru a wani abin da ya faru na <1% (sai dai in ba haka ba) a cikin marasa lafiya da suka karbi Opdualag ko kuma an ruwaito su tare da yin amfani da wasu PD-1/PD-L1 masu hana ƙwayoyin cuta. An ba da rahoton shari'o'i masu tsanani ko masu kisa don wasu daga cikin waɗannan halayen mara kyau: Ccardiac/Vascular: pericarditis, vasculitis; Tsarin Jijiya: meningitis, encephalitis, myelitis da demyelination, myasthenic ciwo / myasthenia gravis (ciki har da exacerbation), Guillain-Barré ciwo, jijiya paresis, autoimmune neuropathy; Ocular: uveitis, iritis, da sauran cututtukan kumburi na ido na iya faruwa. Wasu lokuta ana iya danganta su da cirewar ido. Daban-daban maki na nakasar gani, ciki har da makanta, na iya faruwa. Idan uveitis ya faru a hade tare da sauran IMARs, yi la'akari da ciwo na Vogt-Koyanagi-Harada-kamar ciwo, saboda wannan na iya buƙatar magani tare da steroids na yau da kullum don rage haɗarin hangen nesa na dindindin; Gastrointestinal: pancreatitis ciki har da karuwa a cikin maganin amylase da matakan lipase, gastritis, duodenitis; Musculoskeletal da Haɗin Nama: myositis / polymyositis, rhabdomyolysis (da kuma abubuwan da ke tattare da su ciki har da gazawar koda), arthritis, polymyalgia rheumatica; Endocrine: hypoparathyroidism; Sauran (Hematologic/Immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, tsarin kumburi amsa ciwo, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, rigakafi thrombocytopenic purpura, m gabobin dasawa kin amincewa.

Abubuwan da ke da alaƙa da jiko

Opdualag na iya haifar da mummunan halayen da ke da alaƙa da jiko. Kashe Opdualag a cikin marasa lafiya tare da halayen jiko mai tsanani ko masu barazanar rai. Katsewa ko jinkirin adadin jiko a cikin marasa lafiya tare da matsakaici zuwa matsakaicin halayen jiko. A cikin marasa lafiya waɗanda suka karɓi Opdualag a matsayin jiko na 60-minti, halayen jiko sun faru a cikin 7% (23/355) na marasa lafiya.

Matsalolin Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

M da sauran matsaloli masu tsanani na iya faruwa a cikin marasa lafiya waɗanda ke karɓar allogen hematopoietic stem cell transplantation (HSCT) kafin ko bayan an bi da su tare da mai karɓa na PD-1 / PD-L1 mai hana antibody. Matsalolin da ke da alaƙa da dasawa sun haɗa da hyperacute graft-versus-host disease (GVHD), m GVHD, na kullum GVHD, hepatic veno-occlusive cuta bayan rage tsanani kwandishan, da steroid-bukatar febrile ciwo (ba tare da wani gano cutarwa dalilin). Waɗannan rikice-rikice na iya faruwa duk da tsaka-tsakin jiyya tsakanin PD-1/PD-L1 blockade da allogeneic HSCT.

Bi marasa lafiya a hankali don shaidar rikice-rikice masu alaƙa da dashe kuma ku shiga cikin gaggawa. Yi la'akari da fa'idar tare da haɗarin jiyya tare da mai karɓar mai karɓa na PD-1/PD-L1 yana toshe maganin rigakafi kafin ko bayan HSCT na allogeneic.

Guba ciki-da tayi

Dangane da tsarin aikinta da bayanai daga nazarin dabbobi, Opdualag na iya haifar da cutar da tayin lokacin da aka yi wa mace mai ciki. Nasiha ga mata masu ciki game da yiwuwar haɗarin tayin. Shawartar mata masu yuwuwar haihuwa don amfani da ingantaccen rigakafin hana haihuwa yayin jiyya tare da Opdualag na tsawon watanni 5 aƙalla bayan kashi na ƙarshe na Opdualag.

Haila

Babu bayanai kan kasancewar Opdualag a cikin madarar ɗan adam, illar da yaron da ake shayarwa, ko tasirin samar da madara. Saboda ana iya fitar da nivolumab da relatlimab a cikin madarar ɗan adam kuma saboda yuwuwar haifar da munanan halayen halayen ga yaron da ake shayarwa, shawarci marasa lafiya kada su sha nono yayin jiyya tare da Opdualag kuma na akalla watanni 5 bayan kashi na ƙarshe.

Mummunan Maganganun Magani

A cikin Dangantakar-047, mummunan mummunan sakamako ya faru a cikin 3 (0.8%) marasa lafiya waɗanda aka yi musu magani tare da Opdualag; wadannan sun hada da hemophagocytic lymphohistiocytosis, m edema na huhu, da kuma pneumonitis. Mummunan halayen haɗari sun faru a cikin 36% na marasa lafiya da aka yi wa Opdualag. Mafi yawan mummunan halayen halayen da aka ruwaito a cikin ≥1% na marasa lafiya da aka bi da su tare da Opdualag sune ƙarancin adrenal (1.4%), anemia (1.4%), colitis (1.4%), ciwon huhu (1.4%), myocardial infarction (1.1%), ciwon baya (1.1%), gudawa (1.1%), myocarditis (1.1%), da kuma pneumonitis (1.1%).

Maganganun Magani na gama-gari da nakasassu na Laboratory

Mafi yawan halayen halayen da aka ruwaito a cikin ≥20% na marasa lafiya da aka bi da su tare da Opdualag sune ciwon musculoskeletal (45%), gajiya (39%), rash (28%), pruritus (25%), da zawo (24%).

Abubuwan da suka fi dacewa a cikin dakin gwaje-gwaje da suka faru a cikin ≥20% na marasa lafiya da aka yi wa Opdualag an rage haemoglobin (37%), rage yawan lymphocytes (32%), ƙara AST (30%), ƙara ALT (26%), da rage sodium (24). %).

Please see U.S. Full Prescribing Information for Opdualag.

Alamun OPDIVO + YERVOY

OPDIVO^® (nivolumab), a matsayin wakili ɗaya, an nuna shi don kula da marasa lafiya tare da melanoma maras kyau ko metastatic.

OPDIVO^® (nivolumab), a hade tare da YERVOY^® (ipilimumab), ana nuna shi don kula da marasa lafiya tare da melanoma wanda ba a iya ganowa ko metastatic.

OPDIVO + YERVOY MUHIMMAN BAYANIN TSIRA

Mummunan Maganganun Magani-Mai Mutuwar Kariya

Abubuwan da ba su dace ba na rigakafi da aka jera a nan maiyuwa ba za su haɗa da duk mai yuwuwar mummuna da mummuna mummunan halayen garkuwar jiki ba.

Abubuwan da ba su da kyau a cikin tsarin rigakafi, wanda zai iya zama mai tsanani ko mai kisa, na iya faruwa a kowane tsarin gabobin jiki ko nama. Yayin da halayen rashin lafiya na rigakafi yakan bayyana yayin jiyya, kuma suna iya faruwa bayan dakatar da OPDIVO ko YERVOY. Ganewar farko da gudanarwa suna da mahimmanci don tabbatar da amintaccen amfani da OPDIVO da YERVOY. Saka idanu don alamun da alamun bayyanar cututtuka waɗanda ƙila su zama bayyanar asibiti na rashin daidaituwa na tsaka-tsakin rigakafi. Yi la'akari da sunadarai na asibiti ciki har da enzymes hanta, creatinine, matakin hormone adrenocorticotropic (ACTH), da aikin thyroid a asali da kuma lokaci-lokaci yayin jiyya tare da OPDIVO kuma kafin kowane kashi na YERVOY. A cikin abubuwan da ake zargi da haifar da mummunan sakamako na rigakafi na rigakafi, fara aikin da ya dace don ware wasu cututtukan da suka hada da kamuwa da cuta. Cibiyar kula da lafiya cikin gaggawa, gami da shawarwari na musamman kamar yadda ya dace.

Riƙe ko dakatar da OPDIVO da YERVOY na dindindin ya danganta da tsanani (don Allah a duba sashe na 2 Sashi da Gudanarwa a cikin Cikakken Bayanin Rubuce-rubucen da ke rakiyar). Gabaɗaya, idan ana buƙatar katsewar OPDIVO ko YERVOY ko dakatarwa, gudanar da tsarin maganin corticosteroid (1 zuwa 2 mg / kg / day prednisone ko daidai) har sai an inganta zuwa Grade 1 ko ƙasa da haka. Bayan haɓaka zuwa digiri na 1 ko ƙasa da haka, fara corticosteroid taper kuma ci gaba da yin taper sama da akalla wata 1. Yi la'akari da gudanar da wasu magungunan rigakafi na tsarin a cikin marasa lafiya waɗanda ba a kula da su ba tare da maganin corticosteroid ba. Jagororin sarrafa guba don halayen mara kyau waɗanda ba lallai ba ne su buƙaci tsarin steroids (misali, endocrinopathy da halayen dermatologic) an tattauna su a ƙasa.

Pneumonitis na rigakafi-Mediated

OPDIVO da YERVOY na iya haifar da ciwon huhu mai shiga tsakani. Abubuwan da ke faruwa na pneumonitis sun fi girma a cikin marasa lafiya da suka karbi radiyo na thoracic kafin. A cikin marasa lafiya da ke karɓar OPDIVO monotherapy, ciwon huhu na rigakafi ya faru a cikin 3.1% (61/1994) na marasa lafiya, ciki har da Grade 4 (<0.1%), Grade 3 (0.9%), da Grade 2 (2.1%).

A cikin marasa lafiya da ke karɓar OPDIVO 1 mg / kg tare da YERVOY 3 mg / kg kowane mako 3, ciwon huhu na rigakafi ya faru a cikin 7% (31/456) na marasa lafiya, ciki har da Grade 4 (0.2%), Grade 3 (2.0%), da kuma Darasi na 2 (4.4%).

Colitis na rigakafi-Mediated

OPDIVO da YERVOY na iya haifar da colitis mai shiga tsakani, wanda zai iya zama m. Alamar gama gari da aka haɗa a cikin ma'anar colitis shine gudawa. Cytomegalovirus (CMV) kamuwa da cuta / sake kunnawa an ruwaito a cikin marasa lafiya tare da corticosteroid-refractory immune-mediated colitis. A lokuta na corticosteroid-refractory colitis, yi la'akari da maimaita aikin motsa jiki don keɓance hanyoyin da za a iya amfani da su. A cikin marasa lafiya da ke karɓar OPDIVO monotherapy, colitis na rigakafi ya faru a cikin 2.9% (58/1994) na marasa lafiya, ciki har da Grade 3 (1.7%) da Grade 2 (1%). A cikin marasa lafiya da ke karɓar OPDIVO 1 mg / kg tare da YERVOY 3 mg / kg kowane mako 3, colitis na rigakafi ya faru a cikin 25% (115/456) na marasa lafiya, ciki har da Grade 4 (0.4%), Grade 3 (14%) da Grade. 2 (8%).

Hepatotoxicity na rigakafi da rigakafin rigakafi

OPDIVO da YERVOY na iya haifar da ciwon hanta na rigakafi. A cikin marasa lafiya da ke karɓar OPDIVO monotherapy, ciwon hanta na rigakafi ya faru a cikin 1.8% (35/1994) na marasa lafiya, ciki har da Grade 4 (0.2%), Grade 3 (1.3%), da Grade 2 (0.4%). A cikin marasa lafiya da ke karɓar OPDIVO 1 mg / kg tare da YERVOY 3 mg / kg kowane mako 3, ciwon hanta na rigakafi ya faru a cikin 15% (70/456) na marasa lafiya, ciki har da Grade 4 (2.4%), Grade 3 (11%), da kuma Darasi na 2 (1.8%).

Endocrinopathy na rigakafi-Mediated

OPDIVO da YERVOY na iya haifar da gazawar adrenal na farko ko na biyu, hypophysitis na rigakafi, cututtukan thyroid na rigakafi, da nau'in ciwon sukari na 1, wanda zai iya gabatar da ketoacidosis na ciwon sukari. Riƙe OPDIVO da YERVOY dangane da tsanani (da fatan za a duba sashe na 2 Sashe na 2 Sashi da Gudanarwa a cikin Cikakkun Bayanan Rubutu masu biye). Don digiri na XNUMX ko mafi girma na rashin wadatar adrenal, fara maganin bayyanar cututtuka, gami da maye gurbin hormone kamar yadda aka nuna a asibiti. Hypophysitis na iya gabatar da tare da m bayyanar cututtuka da ke hade da sakamako mai yawa kamar ciwon kai, photophobia, ko lahani na filin gani. Hypophysitis na iya haifar da hypopituitarism; fara maye gurbin hormone kamar yadda aka nuna a asibiti. Thyroiditis na iya faruwa tare da ko ba tare da endocrinopathy ba. Hypothyroidism na iya bin hyperthyroidism; fara maye gurbin hormone ko kulawar likita kamar yadda aka nuna a asibiti. Kula da marasa lafiya don hyperglycemia ko wasu alamu da alamun ciwon sukari; fara jiyya tare da insulin kamar yadda aka nuna a asibiti.

A cikin marasa lafiya da ke karɓar OPDIVO monotherapy, rashin isasshen adrenal ya faru a cikin 1% (20/1994), ciki har da Grade 3 (0.4%) da Grade 2 (0.6%). , Rashin wadatar adrenal ya faru a cikin 1% (3/3), ciki har da Grade 8 (35%), Grade 456 (4%), da Grade 0.2 (3%). A cikin marasa lafiya da ke karɓar OPDIVO 2.4 mg / kg tare da YERVOY 2 mg / kg kowane mako 4.2, rashin isasshen adrenal ya faru a cikin 1% (3/3), gami da Grade 8 (35%), Grade 456 (4%), da Grade 0.2 (3) %).

A cikin marasa lafiya da ke karɓar OPDIVO monotherapy, hypophysitis ya faru a cikin 0.6% (12/1994) na marasa lafiya, ciki har da Grade 3 (0.2%) da Grade 2 (0.3%). A cikin marasa lafiya da ke karɓar OPDIVO 1 mg / kg tare da YERVOY 3 mg / kg kowane mako 3, hypophysitis ya faru a cikin 9% (42/456), ciki har da Grade 3 (2.4%) da Grade 2 (6%).

A cikin marasa lafiya da ke karɓar OPDIVO monotherapy, thyroiditis ya faru a cikin 0.6% (12/1994) na marasa lafiya, ciki har da Grade 2 (0.2%).

A cikin marasa lafiya da ke karɓar OPDIVO monotherapy, hyperthyroidism ya faru a cikin 2.7% (54/1994) na marasa lafiya, ciki har da Grade 3 (<0.1%) da Grade 2 (1.2%). A cikin marasa lafiya da ke karɓar OPDIVO 1 mg / kg tare da YERVOY 3 mg / kg kowane mako 3, hyperthyroidism ya faru a cikin 9% (42/456) na marasa lafiya, ciki har da Grade 3 (0.9%) da Grade 2 (4.2%).

A cikin marasa lafiya da ke karɓar OPDIVO monotherapy, hypothyroidism ya faru a cikin 8% (163/1994) na marasa lafiya, ciki har da Grade 3 (0.2%) da Grade 2 (4.8%). A cikin marasa lafiya da ke karɓar OPDIVO 1 mg / kg tare da YERVOY 3 mg / kg kowane mako 3, hypothyroidism ya faru a cikin 20% (91/456) na marasa lafiya, ciki har da Grade 3 (0.4%) da Grade 2 (11%).

A cikin marasa lafiya da ke karɓar OPDIVO monotherapy, ciwon sukari ya faru a cikin 0.9% (17/1994) na marasa lafiya, gami da Grade 3 (0.4%) da Grade 2 (0.3%), da lokuta 2 na ketoacidosis masu ciwon sukari.

Nephritis na rigakafi-Mediated tare da rashin aikin Renal

OPDIVO da YERVOY na iya haifar da nephritis na rigakafi. A cikin marasa lafiya da ke karɓar OPDIVO monotherapy, nephritis na rigakafi na rigakafi da rashin aikin koda ya faru a cikin 1.2% (23/1994) na marasa lafiya, ciki har da Grade 4 (<0.1%), Grade 3 (0.5%), da Grade 2 (0.6%).

Maganganun Cututtuka Masu Magance Cutar Kwayoyin cuta

OPDIVO na iya haifar da kurji mai tsaka-tsaki na rigakafi ko dermatitis. Exfoliative dermatitis, ciki har da Stevens-Johnson ciwo (SJS), mai guba epidermal necrolysis (TEN), da miyagun ƙwayoyi rash tare da eosinophilia da tsarin bayyanar cututtuka (DRESS) ya faru tare da PD-1 / PD-L1 toshe kwayoyin cuta. Abubuwan da ke motsa jiki da/ko corticosteroids na sama na iya zama isassu don magance rashes masu sauƙi zuwa matsakaici.

YERVOY na iya haifar da kurji mai tsaka-tsaki na rigakafi ko dermatitis, gami da bullous da exfoliative dermatitis, SJS, TEN, da DRESS. Abubuwan da ke motsa jiki da/ko corticosteroids na sama na iya zama isassu don magance rashes masu laushi zuwa matsakaici marasa ƙarfi/exfoliative.

Riƙe ko dakatar da OPDIVO da YERVOY na dindindin ya danganta da tsanani (don Allah a duba sashe na 2 Sashi da Gudanarwa a cikin Cikakken Bayanin Rubuce-rubucen da ke rakiyar).

A cikin marasa lafiya da ke karɓar OPDIVO monotherapy, raƙuman ƙwayar cuta na rigakafi ya faru a cikin 9% (171/1994) na marasa lafiya, ciki har da Grade 3 (1.1%) da Grade 2 (2.2%). A cikin marasa lafiya da ke karɓar OPDIVO 1 mg / kg tare da YERVOY 3 mg / kg kowane mako 3, ɓacin rai na rigakafi ya faru a cikin 28% (127/456) na marasa lafiya, ciki har da Grade 3 (4.8%) da Grade 2 (10%).

Sauran Maganganun Magance Magance Rigakafin Kariya

Abubuwan da suka biyo baya na asibiti mai mahimmanci na rigakafin rigakafi sun faru a cikin abin da ya faru na <1% (sai dai in ba haka ba) a cikin marasa lafiya waɗanda suka karɓi OPDIVO monotherapy ko OPDIVO a hade tare da YERVOY ko an ba da rahoton tare da amfani da wasu toshewar PD-1/PD-L1. maganin rigakafi. An ba da rahoton lokuta masu tsanani ko m ga wasu daga cikin waɗannan halayen halayen: zuciya / jijiyoyin jini: myocarditis, pericarditis, vasculitis; tsarin juyayi: meningitis, encephalitis, myelitis da demyelination, myasthenic ciwo / myasthenia gravis (ciki har da exacerbation), Guillain-Barré ciwo, jijiya paresis, autoimmune neuropathy; ido: uveitis, iritis, da sauran cututtukan kumburi na ido na iya faruwa; gastrointestinal: pancreatitis don haɗawa da karuwa a cikin maganin amylase da matakan lipase, gastritis, duodenitis; musculoskeletal da connective nama: myositis/polymyositis, rhabdomyolysis, da kuma abubuwan da ke tattare da su ciki har da gazawar koda, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; sauran (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), tsarin kumburi amsa ciwo, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, rigakafi thrombocytopenic purpura, m gabobin dasawa kin amincewa.

Bugu da ƙari ga halayen da ba su da kyau na rigakafi da aka jera a sama, a fadin gwaje-gwaje na asibiti na YERVOY monotherapy ko a hade tare da OPDIVO, waɗannan halayen rashin lafiya na asibiti masu mahimmanci na asibiti, wasu tare da sakamako mai mutuwa, sun faru a cikin <1% na marasa lafiya sai dai in ba haka ba: tsarin juyayi: autoimmune neuropathy (2%), ciwo na myasthenic / myasthenia gravis, rashin aikin motsa jiki; zuciya da jijiyoyin jini: angiopathy, na wucin gadi arteritis; ido: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); sauran (hematologic/immune): conjunctivitis, cytopenia (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.

Wasu shari'o'in IMAR na ido suna iya haɗa su tare da cirewar ido. Daban-daban maki na nakasar gani, ciki har da makanta, na iya faruwa. Idan uveitis ya faru a hade tare da sauran halayen rashin lafiya na rigakafi, la'akari da ciwo na Vogt-Koyanagi-Harada-kamar ciwo, wanda aka lura a cikin marasa lafiya da ke karɓar OPDIVO da YERVOY, saboda wannan na iya buƙatar magani tare da corticosteroids na tsarin don rage haɗarin hangen nesa na dindindin. hasara.

Abubuwan da ke da alaƙa da jiko

OPDIVO da YERVOY na iya haifar da mummunan halayen da ke da alaƙa da jiko. Kashe OPDIVO da YERVOY a cikin marasa lafiya masu tsanani (Grade 3) ko barazanar rayuwa (Grade 4) halayen da suka shafi jiko. Katsewa ko jinkirin adadin jiko a cikin marasa lafiya tare da ƙananan halayen (Grade 1) ko matsakaici (Grade 2) masu alaƙa da jiko.

A cikin marasa lafiya da ke karɓar OPDIVO monotherapy a matsayin jiko na minti 60, halayen jiko sun faru a cikin 6.4% (127/1994) na marasa lafiya. A cikin gwaji na daban wanda marasa lafiya suka karbi OPDIVO monotherapy a matsayin jiko na 60-minti ko jiko na minti 30, halayen da suka shafi jiko sun faru a cikin 2.2% (8/368) da 2.7% (10/369) na marasa lafiya, bi da bi. Bugu da ƙari, 0.5% (2/368) da 1.4% (5/369) na marasa lafiya, bi da bi, sun sami sakamako mara kyau a cikin sa'o'i 48 na jiko wanda ya haifar da jinkirin kashi, dakatarwa na dindindin ko riƙewa na OPDIVO.

A cikin marasa lafiya na melanoma suna karɓar OPDIVO 1 mg / kg tare da YERVOY 3 mg / kg kowane mako 3, halayen jiko sun faru a cikin 2.5% (10/407) na marasa lafiya.

Matsalolin Allogeneic Hematopoietic Stem Cell dasawa

M da sauran matsaloli masu tsanani na iya faruwa a cikin marasa lafiya waɗanda ke karɓar allogen hematopoietic stem cell transplantation (HSCT) kafin ko bayan an bi da su tare da OPDIVO ko YERVOY. Rikice-rikicen da ke da alaƙa sun haɗa da hyperacute graft-versus-host-cuta (GVHD), m GVHD, na kullum GVHD, hepatic veno-occlusive cuta (VOD) bayan rage tsanani kwandishan, da steroid-bukatar ciwon zazzaɓi (ba tare da gano dalilin kamuwa da cuta). Waɗannan rikice-rikice na iya faruwa duk da tsaka-tsakin jiyya tsakanin OPDIVO ko YERVOY da allogeneic HSCT.

Bi marasa lafiya a hankali don shaidar rikice-rikice masu alaƙa da dashe kuma ku shiga cikin gaggawa. Yi la'akari da fa'idar tare da haɗarin jiyya tare da OPDIVO da YERVOY kafin ko bayan HSCT na allogeneic.

Guba ciki-da tayi

Dangane da tsarin aikinta da binciken binciken dabbobi, OPDIVO da YERVOY na iya haifar da cutar da tayin lokacin da aka yi wa mace mai ciki. Tasirin YERVOY na iya zama mafi girma a cikin na biyu da na uku na ciki. Nasiha ga mata masu ciki game da yiwuwar haɗarin tayin. Shawarar mata masu yuwuwar haifuwa don amfani da ingantaccen rigakafin hana haihuwa yayin jiyya tare da OPDIVO da YERVOY kuma na akalla watanni 5 bayan kashi na ƙarshe.

Ƙara yawan mace-mace a cikin marasa lafiya tare da Multiple Myeloma lokacin da aka Ƙara OPDIVO zuwa Thalidomide Analogue da Dexamethasone

A cikin gwaje-gwajen asibiti bazuwar a cikin marasa lafiya tare da myeloma da yawa, ƙari na OPDIVO zuwa analog na thalidomide da dexamethasone ya haifar da karuwar mace-mace. Jiyya na marasa lafiya tare da myeloma da yawa tare da PD-1 ko PD-L1 mai toshe antibody a hade tare da analog na thalidomide da dexamethasone ba a ba da shawarar a waje da gwajin asibiti da aka sarrafa ba.

Haila

Babu bayanai kan kasancewar OPDIVO ko YERVOY a cikin madarar ɗan adam, illar da yaron da aka shayar da shi, ko illar samar da madara. Saboda yuwuwar mummunan halayen halayen ga yara masu shayarwa, shawarci mata kada su sha nono yayin jiyya da kuma watanni 5 bayan kashi na ƙarshe.

Mummunan Maganganun Magani

A cikin Checkmate 037, mummunan halayen halayen sun faru a cikin 41% na marasa lafiya da ke karɓar OPDIVO (n=268). Matsayi na 3 da 4 mara kyau sun faru a cikin 42% na marasa lafiya da ke karɓar OPDIVO. Mafi yawan halayen miyagun ƙwayoyi na 3 da 4 da aka ruwaito a cikin 2% zuwa <5% na marasa lafiya da ke karɓar OPDIVO sun kasance ciwon ciki, hyponatremia, ƙara yawan aspartate aminotransferase, da kuma ƙara yawan lipase. A cikin Checkmate 066, mummunan halayen halayen sun faru a cikin 36% na marasa lafiya da ke karɓar OPDIVO (n=206). Matsayi na 3 da 4 mara kyau sun faru a cikin 41% na marasa lafiya da ke karɓar OPDIVO. Mafi yawan halayen halayen 3 da 4 da aka ruwaito a cikin ≥2% na marasa lafiya da ke karɓar OPDIVO sun kasance karuwa gamma-glutamyltransferase (3.9%) da gudawa (3.4%). A cikin Checkmate 067, munanan halayen halayen (74% da 44%), munanan halayen da ke haifar da dakatarwa na dindindin (47% da 18%) ko zuwa jinkirin allurai (58% da 36%), da halayen mara kyau na Grade 3 ko 4 (72% da 51%) duk sun faru akai-akai a cikin OPDIVO da hannun YERVOY (n=313) dangane da hannun OPDIVO (n=313). Mafi yawan lokuta (≥10%) munanan halayen haɗari a cikin OPDIVO da hannun YERVOY da hannun OPDIVO, bi da bi, sune gudawa (13% da 2.2%), colitis (10% da 1.9%), da pyrexia (10% da 1.0). %).

Maganganun Magani na gama gari

A cikin Checkmate 037, mafi yawan mummunan halayen (≥20%) da aka ruwaito tare da OPDIVO (n=268) ya kasance kurji (21%). A cikin Checkmate 066, mafi yawan abubuwan da ba su da kyau (≥20%) da aka ruwaito tare da OPDIVO (n = 206) vs dacarbazine (n = 205) sun kasance gajiya (49% vs 39%), ciwon musculoskeletal (32% vs 25%), rash. (28% vs 12%), da pruritus (23% vs 12%). A cikin Checkmate 067, mafi yawan halayen (≥20%) a cikin OPDIVO tare da hannun YERVOY (n=313) sun kasance gajiya (62%), gudawa (54%), kurji (53%), tashin zuciya (44%), pyrexia (40%), pruritus (39%), ciwon musculoskeletal (32%), amai (31%), rage cin abinci (29%), tari (27%), ciwon kai (26%), dyspnea (24%), Cutar cututtuka na numfashi na sama (23%), arthralgia (21%), da karuwar transaminases (25%). A cikin Checkmate 067, mafi yawan (≥20%) mummunan halayen a cikin hannun OPDIVO (n = 313) sun kasance gajiya (59%), rash (40%), ciwon musculoskeletal (42%), zawo (36%), tashin zuciya. (30%), tari (28%), pruritus (27%), kamuwa da cuta na numfashi na sama (22%), rage cin abinci (22%), ciwon kai (22%), maƙarƙashiya (21%), arthralgia (21%) , da amai (20%).

Please see US Full Prescribing Information for OPDIVO and YERVOY.

Bristol Myers Squibb: Ƙirƙirar kyakkyawar makoma ga masu fama da cutar kansa

Bristol Myers Squibb ya sami wahayi ta hanyar hangen nesa guda - yana canza rayuwar marasa lafiya ta hanyar kimiyya. Manufar binciken kansar kamfanin ita ce isar da magungunan da ke baiwa kowane majiyyaci rayuwa mai inganci da lafiya da kuma yin yuwuwar warkarwa. Gina kan gado a cikin nau'ikan cututtukan daji masu yawa waɗanda suka canza tsammanin rayuwa ga mutane da yawa, masu binciken Bristol Myers Squibb suna binciko sabbin iyakoki a cikin keɓaɓɓen magani, kuma ta hanyar sabbin hanyoyin dijital, suna jujjuya bayanai zuwa abubuwan fahimta waɗanda ke haɓaka hankalinsu. Ƙwararrun ilimin kimiyya mai zurfi, iyakoki da kuma hanyoyin ganowa suna ba kamfanin damar duba ciwon daji daga kowane kusurwa. Ciwon daji na iya samun fahimtar sassa da yawa na rayuwar majiyyaci, kuma Bristol Myers Squibb ta himmatu wajen ɗaukar matakai don magance duk fannonin kulawa, daga ganewar asali zuwa tsira. Domin a matsayin jagora a kula da ciwon daji, Bristol Myers Squibb yana aiki don ƙarfafa duk masu ciwon daji don samun kyakkyawar makoma.

Game da Tallafin Samun Haƙuri na Bristol Myers Squibb

Bristol Myers Squibb ya ci gaba da jajircewa wajen ba da taimako domin masu fama da cutar kansa da ke buƙatar magungunan mu su sami damar yin amfani da su da kuma hanzarta lokacin jiyya.

Taimakon Samun damar BMS^®, the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Supportat 1-800-861-0048 or by visiting www.bmsaccesssupport.com.

Game da haɗin gwiwar Bristol Myers Squibb da Ono Pharmaceutical Haɗin gwiwar

A cikin 2011, ta hanyar yarjejeniyar haɗin gwiwa tare da Ono Pharmaceutical Co., Bristol Myers Squibb ya faɗaɗa haƙƙoƙin yanki don haɓakawa da kasuwanci. Abin al'ajabi a duk duniya, sai dai a Japan, Koriya ta Kudu da Taiwan, inda Ono ta riƙe duk haƙƙoƙin ginin a lokacin. A ranar 23 ga Yuli, 2014, Ono da Bristol Myers Squibb sun kara fadada yarjejeniyar haɗin gwiwar dabarun kamfanoni don haɓakawa tare da tallata magungunan rigakafi da yawa - a matsayin wakilai guda ɗaya da tsarin haɗin gwiwa - ga marasa lafiya da ke fama da cutar kansa a Japan, Koriya ta Kudu da Taiwan.

Game da Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

Celgene da Juno Therapeutics su ne gaba ɗaya mallakar rassan Bristol-Myers Squibb Kamfanin. A wasu ƙasashe a wajen Amurka, saboda dokokin gida, Celgene da Juno Therapeutics ana kiran su, Celgene, kamfanin Bristol Myers Squibb da Juno Therapeutics, kamfanin Bristol Myers Squibb.

Bayanin Gargaɗi Game da Bayanin Gaba-Gaba

Wannan sanarwar manema labarai ta ƙunshi "kalmomi masu kallon gaba" a cikin ma'anar Dokar sake fasalin Shari'a ta Securities na 1995 game da, a tsakanin sauran abubuwa, bincike, haɓakawa da tallace-tallace na samfuran magunguna. Duk maganganun da ba bayanan bayanan tarihi ba ne, ko kuma ana iya ganin su, kalamai ne masu sa ido. Irin waɗannan maganganun sa ido sun dogara ne akan tsammanin da ake tsammani na yanzu game da sakamakon kuɗin kuɗinmu na gaba, manufofinmu, tsare-tsare da manufofinmu kuma sun haɗa da haɗari, zato da rashin tabbas, gami da abubuwan ciki ko na waje waɗanda zasu iya jinkirtawa, karkatar da su ko canza kowane ɗayansu a gaba. shekaru da yawa, waɗanda ke da wuyar tsinkaya, na iya zama sama da ikonmu kuma suna iya haifar da sakamakon kuɗaɗen mu na gaba, burinmu, tsare-tsare da manufofin mu su bambanta ta zahiri da waɗanda aka bayyana a ciki, ko kuma a fayyace ta, maganganun. Waɗannan haɗari, zato, rashin tabbas da sauran abubuwan sun haɗa da, da sauransu, ko Opdualag^TM (nivolumab da relatlimab-rmbw) za su yi nasara ta kasuwanci don alamar da aka bayyana a cikin wannan sanarwar manema labaru, duk wani yarda da tallace-tallace, idan an ba shi, na iya samun iyakacin iyaka akan amfani da su, da kuma ci gaba da amincewa da irin wannan dan takarar samfurin don irin wannan alamar da aka bayyana a cikin wannan jarida. saki na iya kasancewa akan tabbaci da bayanin fa'idodin asibiti a cikin gwaje-gwajen tabbatarwa. Ba za a iya tabbatar da bayanin sa ido ba. Ya kamata a kimanta maganganun gaba-gaba a cikin wannan sanarwar manema labarai tare da yawancin haɗari da rashin tabbas waɗanda ke shafar kasuwanci da kasuwa na Bristol Myers Squibb, musamman waɗanda aka gano a cikin sanarwar taka tsantsan da abubuwan haɗari a cikin Rahoton Shekara-shekara na Bristol Myers Squibb akan Form 10-K don shekarar ta ƙare Disamba 31, 2021, kamar yadda aka sabunta ta Rahotannin mu na Kwata-kwata na gaba akan Form 10-Q, Rahotanni na Yanzu akan Form 8-K da sauran takardun shiga tare da Hukumar Tsaro da Musanya. Bayanan hangen nesa da aka haɗa a cikin wannan takarda ana yin su ne kawai daga ranar wannan takarda kuma sai dai idan aka buƙata ta hanyar doka mai dacewa, Bristol Myers Squibb ba ta da alhakin sabunta ko sake duba duk wata sanarwa ta gaba, ko dai a sakamakon haka. sabon bayani, abubuwan da zasu faru nan gaba, canza yanayi ko akasin haka.

References

1. Opdualag Shirya Bayani. Opdualag Bayanan Samfur na Amurka. An sabunta ta ƙarshe: Maris 2022. Princeton, NJ: Kamfanin Bristol-Myers Squibb.
2. Tawbi HA, Schadendorf D, Lipson EJ, et al. Relatlimab da nivolumab tare da nivolumab a cikin ci gaban melanoma da ba a kula da su ba. N Engl J Med. 2022; 386: 24-34.
3. Hodi FS, Chiarion-Sileni V, Gonzalez R, et al. Nivolumab da ipilimumab ko nivolumab kadai tare da ipilimumab kadai a cikin ci gaban melanoma (CheckMate 067): Sakamakon shekaru 4 na cibiyar da yawa, bazuwar, gwaji na lokaci 3. Lancet Oncol. 2018;19(11): 1480-1492.
4. Cibiyar Abinci da Magunguna ta Amurka. Shirye-shiryen Pilot Review na Kankara na Gaskiya.