April 2022: Iyo US Food and Drug Administration (FDA) yakabvumidza Opdualag (nivolumab uye relatlimab-rmbw), itsva, yekutanga-mu-kirasi yakagadziriswa-dose musanganiswa we nivolumab uye relatlimab inoshandiswa sechinhu chimwe chete intravenous infusion, kuitira kurapwa kwevanhu vakuru nevana vane makore gumi nemaviri uye kupfuura vane unresectable kana metastatic melanoma. Mvumo yacho yakavakirwa paRELATIVITY-12 Phase 047/2 kudzidza, iyo yakaenzanisa Opdualag (n=3) ne nivolumab chete (n=355) muhuwandu hwevarwere ve359.
Muyedzo wakasangana nemagumo ayo ekutanga, kufambira mberi-kusina kupona (PFS), uye Opdualag yakapetwa kaviri iyo yepakati PFS kana ichienzaniswa nivolumab monotherapy, mwedzi 10.1 (95% Confidence Interval [CI]: 6.4 kusvika 15.7) zvichienderana nemwedzi 4.6 (95% CI: 3.4 kusvika 5.6); (Hazard Ratio [HR] 0.75; 95% CI: 0.62 kusvika 0.92, P= 0.0055).1 The Opdualag chengetedzo mbiri yaive yakafanana neyakambotaurwa nezve nivolumab.1,2 Hapana zviitiko zvitsva zvekuchengetedza zvakaonekwa nemusanganiswa kana uchienzaniswa ne nivolumab monotherapy.1,2 Giredhi 3/4 zviitiko zvakashata zvine chekuita nezvinodhaka zvaive 18.9% mu Opdualag ruoko rwakaenzaniswa ne9.7% muruwoko rwe nivolumab.2 Zviitiko zvakashata zvine chekuita nezvinodhaka zvinotungamira pakuregedzwa zvaive 14.6% mu Opdualag ruoko rwakaenzaniswa ne6.7% muruwoko rwe nivolumab.2
"Kubva pakabvumidzwa yekutanga immune checkpoint inhibitor makore anopfuura gumi apfuura, takaona immunotherapy, yoga uye pamwe chete, ichichinja marapirwo evarwere vane melanoma yakakura," akadaro F. Stephen Hodi, MD, director weMelanoma Center. uye Center for Immuno-Oncology paDana-Farber Cancer Institute.3 “Mvumo yanhasi inokosha zvikuru, sezvairi inounza musanganiswa mutsva weaviri immunotherapies anogona kushanda pamwechete kubatsira kuvandudza anti-bundu mhinduro nekutarisa maviri akasiyana ekudzivirira ekudzivirira zvirwere - LAG-3 uye PD-1. "1,2
Opdualag inobatanidzwa neNyevero & Dziviriro dzinotevera: zvakakomba uye zvinouraya immune-mediated adverse reactions (IMARs) kusanganisira pneumonitis, colitis, hepatitis, endocrinopathies, nephritis ine renal dysfunction, dermatologic adverse reactions, myocarditis uye mamwe maitiro anokanganisa immune-mediated; infusion-yakabatana maitiro; matambudziko eallogeneic hematopoietic stem cell transplantation (HSCT); uye embryo-fetal toxicity.1 Ndapota ona Ruzivo Rwakakosha Pakuchengetedza pazasi.
"Kunyangwe takafambira mberi zvikuru mukurapa melanoma mumakore gumi apfuura, takazvipira kuwedzera nzira dzekurapa dzevarwere ava," akadaro Samit Hirawat, mukuru wezvekurapa, pasi rose, Bristol Myers Squibb.3 "Kuvharisa LAG-3 ine relatlimab, mune yakagadziriswa-dosi musanganiswa ne nivolumab, inomiririra nzira nyowani yekurapa inovaka pane yedu nhaka yekuunza hunyanzvi hwekudzivirira immunotherapy kuvarwere. Kutenderwa kwemushonga mutsva unosanganisira yedu yechitatu yakasarudzika checkpoint inhibitor inoratidza danho rakakosha rekupa varwere dzimwe sarudzo kupfuura monotherapy."
Lymphocyte activation gene-3 (LAG-3) uye yakarongwa rufu-1 (PD-1) maviri akasiyana inhibitory immune checkpoints ayo anowanzo kuratidzwa pabundu-infiltrating lymphocytes, nokudaro zvichipa kune tumor-mediated T-cell kuneta.2 Iko kusanganiswa kwenivolumab (anti-PD-1) uye relatlimab (anti-LAG-3) inoguma nekuwedzera T-cell activation kana ichienzaniswa nebasa reimwe antibody chete.1 Relatlimab (yakabatana ne nivolumab) ndiyo yekutanga LAG-3-inovharira masoja ekudzivirira chirwere kuratidza bhenefiti muChidzidzo cheChitatu.1 Ndiyo yechitatu yekutarisa inhibitor (pamwe ne-anti-PD-1 uye anti-CTLA-4) yeBristol Myers Squibb.
"Mvumo yanhasi inhau dzinonakidza uye inopa tariro itsva kunharaunda yemelanoma. Kuvepo kwemusanganiswa wekurapa uyu kunogona kugonesa varwere kuti vabatsirwe kubva kune itsva, yekutanga-mu-kirasi mbiri mbiri immunotherapy, "akadaro Michael Kaplan, mutungamiri uye CEO, Melanoma Research Alliance.
Iyo FDA-inotenderwa dosing yevarwere vakuru uye varwere vevana vane makore gumi nemaviri kana kupfuura vanorema zvishoma 12 kg ndeye 40 mg nivolumab uye 480 mg relatlimab inopihwa intravenously mavhiki mana ega ega.1 Iyo yakakurudzirwa dosi yevarwere vevana vane makore gumi nemaviri kana kupfuura avo vanorema isingasviki 12 kg, uye varwere vevana vari pasi pemakore gumi nemaviri, haisati yatangwa.1
Ichi chikumbiro chakatenderwa pasi peiyo FDA's Real-Time Oncology Ongororo (RTOR) mutyairi chirongwa, icho chine chinangwa chekuona kuti kurapa kwakachengeteka uye kunoshanda kunowanikwa kune varwere nekukurumidza sezvinobvira.4 Ongororo iyi yakaitwa zvakare pasi pechirongwa cheFDA's Project Orbis, icho chakagonesa kuongororwa pamwe chete nevakuru vehutano muAustralia, Brazil neSwitzerland, uko chikumbiro chinoramba chiri kuongororwa.
About RELATIVITY-047
RELATIVITY-047 chidzidzo chepasi rose, chisina kurongeka, chakapetwa kaviri-mapofu Phase 2/3 inoongorora yakagadziriswa-dose musanganiswa wenivolumab uye relatlimab versus nivolumab chete muvarwere vane metastatic isati yarapwa kana isina kurongeka melanoma.1,2 Muedzo wacho waisabatanidzira varwere vane chirwere che autoimmune, mamiriro ekurapa anoda systemic kurapwa ane mwero kana yakakwira dose corticosteroids kana immunosuppressive mishonga, uveal melanoma, uye inoshanda kana isina kurapwa huropi kana leptomeningeal metastases.1 Mhedziso yekutanga yekuedza ndeyekufambira mberi-kusina kupona (PFS) kunotsanangurwa neBlinded Independent Central Review (BICR) vachishandisa Response Evaluation Criteria muSolid Tumors (RECIST v1.1).1 Iwo echipiri ekupedzisira kupona kwese (OS) uye chinangwa chekupindura mwero (ORR).1 Zvose zvevarwere ve714 zvakasarudzwa 1: 1 kuti vagamuchire kusanganiswa-dose kusanganiswa kwe nivolumab (480 mg) uye relatlimab (160 mg) kana nivolumab (480 mg) ne intravenous infusion mavhiki mana ose kusvikira kufambira mberi kwechirwere kana kusagashira chepfu.1
Sarudza Kuchengetedzwa Profile Kubva RELATIVITY-047
Zvakaipa zvinokonzeresa kusaenderera mberi kwe Opdualag yakaitika mu18% yevarwere.1Opdualag yakavhiringidzwa nekuda kwekuita kwakashata mu43% yevarwere.1 Zvakakomba zvakashata zvakaitika mu36% yevarwere vakarapwa Opdualag.1 Zvakanyanya kuitika (≥1%) zvakakomba zvakashata zvaive adrenal insufficiency (1.4%), anemia (1.4%), colitis (1.4%), mabayo (1.4%), acute myocardial infarction (1.1%), kurwadziwa kwemusana (1.1% ), manyoka (1.1%), myocarditis (1.1%), uye pneumonitis (1.1%).1 Kuita kwakashata kwakaitika muvatatu (0.8%) varwere vakarapwa Opdualag uye yaisanganisira hemophagocytic lymphohistiocytosis, acute edema yemapapu, uye pneumonitis.1 Zvakanyanya kuitika (≥20%) maitiro asina kunaka aive kurwadziwa kwemusculoskeletal (45%), kuneta (39%), mapundu (28%), pruritus (25%), uye manyoka (24%).1 The Opdualag chengetedzo mbiri yaive yakafanana neyakambotaurwa nezve nivolumab.1,2 Hapana zviitiko zvitsva zvekuchengetedza zvakaonekwa nemusanganiswa kana uchienzaniswa ne nivolumab monotherapy.1,2 Giredhi 3/4 zviitiko zvakashata zvine chekuita nezvinodhaka zvaive 18.9% mu Opdualag ruoko rwakaenzaniswa ne9.7% muruwoko rwe nivolumab.2 Zviitiko zvakashata zvine chekuita nezvinodhaka zvinotungamira pakuregedzwa zvaive 14.6% mu Opdualag ruoko rwakaenzaniswa ne6.7% muruwoko rwe nivolumab.2
About Melanoma
Melanoma imhando yegomarara reganda rinoratidzwa nekusadzora kukura kwemasero anogadzira pigment (melanocytes) ari muganda.5 Metastatic melanoma ndiyo inouraya chirwere ichi uye inoitika kana gomarara richipararira kupfuura pamusoro peganda richienda kune dzimwe nhengo.5,6 Nhamba ye melanoma yave ichiwedzera zvishoma nezvishoma kwemakore makumi matatu apfuura.5,6 MuUnited States, vangangoita 99,780 kutsva kwechirwere che melanoma uye vangangosvika zviuru zvinomwe nemazana matanhatu nemazana matanhatu vakafa vanofungidzirwa kuti muna 7,650.5 Melanoma inogona kurapika zvakanyanya kana yakabatwa ichangotanga; zvisinei, mazinga ekupona anogona kuderera sezvo hosha inofambira mberi.6
OPDUALAG INDICATION
Opdualag TM (nivolumab uye relatlimab-rmbw) inoratidzirwa kurapwa kwevakuru uye vana varwere vane makore gumi nemaviri kana kupfuura vane unresectable kana metastatic melanoma.
OPDUALAG INOKOSHA KUCHENGETEKA RUZIVO
Yakakomba uye Inouraya Immune-Mediated Dzakashata Reaction
Immune-mediated adverse reactions (IMARs) yakanyorwa pano inogona kunge isingasanganisire akashata uye anouraya immune-mediated akashata maitiro.
IMAR inogona kunge yakaoma kana kuuraya, inogona kuitika mune chero nhengo system kana tishu. IMAR inogona kuitika chero nguva mushure mekutanga kurapwa neLAG-3 uye PD-1/PD-L1 inovharira masoja ekudzivirira chirwere. Nepo maIMAR achiwanzo ratidza panguva yekurapa, anogona zvakare kuitika mushure mekumiswa kweOpdualag. Kuzivikanwa kwekutanga uye manejimendi eIMAR kwakakosha kuti uve nechokwadi chekushandiswa kwakachengeteka. Chengetedza varwere zvakanyanya kune zviratidzo uye zviratidzo zvinogona kunge zviri zvekiriniki kuratidzwa kweari pasi IMARs. Ongorora makiriniki emakemikari anosanganisira chiropa enzymes, creatinine, uye thyroid basa pakutanga uye nguva nenguva panguva yekurapa. Muzviitiko zvevanofungidzirwa kuti IMARs, tanga kushanda kwakakodzera kusasanganisa mamwe maitiro, kusanganisira kutapukira. Institute medical management nekukasira, kusanganisira kubvunzana nehunyanzvi sezvazvinokodzera.
Kunyima kana kuregedza zvachose Opdualag zvichienderana nekuomarara (ndapota ona chikamu 2 Chiyero uye Kutonga mune inoperekedza Ruzivo Rwakazara rwekurongeka). Kazhinji, kana Opdualag ichida kuvhiringwa kana kuregedzwa, shandisa systemic corticosteroid therapy (1 kusvika 2 mg/kg/day prednisone kana yakaenzana) kusvika pakuvandudzwa kusvika Giredhi 1 kana zvishoma. Paunenge uchivandudza kuGiredhi 1 kana zvishoma, tanga corticosteroid taper uye ramba uchiita taper kupfuura mwedzi mumwe chete. Funga nezvekutonga kweimwe systemic immunosuppressants muvarwere vane IMAR isingadzorerwe necorticosteroid therapy. Toxicity management nhungamiro yeakaipa isingade systemic steroids (semuenzaniso, endocrinopathies uye dermatologic reactions) inokurukurwa pazasi.
Immune-Inopindirana Pneumonitis
Opdualag inogona kukonzera immune-mediated pneumonitis, inogona kuuraya. Mune varwere vanorapwa nemamwe PD-1 / PD-L1 inovharira masoja ekudzivirira chirwere, chiitiko chepneumonitis chakakwira kune varwere vakambogamuchira musana wechipfuva. Immune-mediated pneumonitis yakaitika mu3.7% (13/355) yevarwere vanogamuchira Opdualag, kusanganisira Giredhi 3 (0.6%), uye Giredhi 2 (2.3%) maitiro akashata. Pneumonitis yakakonzera kuregedzwa zvachose kweOpdualag mu0.8% uye kunyimwa kweOpdualag mu1.4% yevarwere.
Immune-Inopindirana Colitis
Opdualag inogona kukonzera immune-mediated colitis, inotsanangurwa sekuda kushandiswa kwecorticosteroids uye hapana yakajeka imwe etiology. Chiratidzo chakajairika chaisanganisirwa mutsanangudzo yecolitis yaive manyoka. Cytomegalovirus utachiona / reactivation yakataurwa kune varwere vane corticosteroid-refractory immune-mediated colitis. Muzviitiko zve corticosteroid-refractory colitis, funga kudzokorora kushanda kwehutachiona kuti usasanganise mamwe etiologies.
Diarrhea-mediated diarrhea kana colitis yakaitika mu7% (24/355) yevarwere vanogamuchira Opdualag, kusanganisira Giredhi 3 (1.1%) uye Giredhi 2 (4.5%) maitiro akashata. Colitis yakakonzera kumiswa zvachose kweOpdualag mu2% uye kunyimwa kweOpdualag mu2.8% yevarwere.
Immune-Mediated Hepatitis
Opdualag inogona kukonzera immune-mediated hepatitis, inotsanangurwa sekuda kushandiswa kwecorticosteroids uye hapana yakajeka imwe etiology.
Immune-mediated hepatitis yakaitika mu6% (20/355) yevarwere vaigamuchira Opdualag, kusanganisira Giredhi 4 (0.6%), Grade 3 (3.4%), uye Giredhi 2 (1.4%) maitiro akashata. Hepatitis yakatungamira kumisa zvachose Opdualag mu1.7% uye kunyimwa kweOpdualag mu2.3% yevarwere.
Immune-Inopindirana Endocrinopathies
Opdualag inogona kukonzera yekutanga kana yechipiri adrenal insufficiency, hypophysitis, thyroid kusagadzikana, uye Type 1 chirwere cheshuga mellitus, chinogona kunge chiripo nechirwere cheshuga ketoacidosis. Kunyima kana kuregedza zvachose Opdualag zvichienderana nekuomarara (ndapota ona chikamu 2 Dosage uye Kutonga mune inoperekedza Ruzivo Rwakazara).
Kune Giredhi 2 kana yepamusoro adrenal insufficiency, tanga kurapwa kwechiratidzo, kusanganisira kutsiva mahormone sezvakaratidzwa nekiriniki. Mune varwere vanogamuchira Opdualag, adrenal insufficiency yakaitika mu4.2% (15/355) yevarwere vanogamuchira Opdualag, kusanganisira Giredhi 3 (1.4%) uye Giredhi 2 (2.5%) yakashata maitiro. Kusakwana kweAdrenal kwakakonzera kuregedzwa zvachose kweOpdualag mu1.1% uye kunyimwa kweOpdualag mu0.8% yevarwere.
Hypophysitis inogona kuunza neacute zviratidzo zvine chekuita nekuwanda mhedzisiro senge musoro, photophobia, kana kutadza kwekuona munda. Hypophysitis inogona kukonzera hypopituitarism; tanga kuchinjwa kwehomoni sezvinoratidzwa nekliniki. Hypophysitis yakaitika mu2.5% (9/355) yevarwere vanogamuchira Opdualag, kusanganisira Giredhi 3 (0.3%) uye Giredhi 2 (1.4%) maitiro akashata. Hypophysitis yakakonzera kumiswa zvachose kweOpdualag mu0.3% uye kunyimwa kweOpdualag mu0.6% yevarwere.
Thyroiditis inogona kuuya kana isina endocrinopathy. Hypothyroidism inogona kutevera hyperthyroidism; tanga kutsiva kwehomoni kana kurapwa sezvakaratidzwa nekiriniki. Thyroiditis yakaitika mu2.8% (10/355) yevarwere vanogamuchira Opdualag, kusanganisira Giredhi 2 (1.1%) maitiro akashata. Thyroiditis haina kutungamira mukuregedzwa zvachose kweOpdualag. Thyroiditis yakakonzera kunyimwa kweOpdualag mu 0.3% yevarwere. Hyperthyroidism yakaitika mu6% (22/355) yevarwere vanogamuchira Opdualag, kusanganisira Giredhi 2 (1.4%) maitiro asina kunaka. Hyperthyroidism haina kutungamirira kukuregererwa zvachose kweOpdualag. Hyperthyroidism yakakonzera kunyimwa kweOpdualag mu 0.3% yevarwere. Hypothyroidism yakaitika mu17% (59/355) yevarwere vanogamuchira Opdualag, kusanganisira Giredhi 2 (11%) maitiro akashata. Hypothyroidism yakakonzera kubviswa zvachose kweOpdualag mu0.3% uye kunyimwa kweOpdualag mu2.5% yevarwere.
Tarisa varwere ve hyperglycemia kana zvimwe zviratidzo uye zviratidzo zvechirwere cheshuga; tanga kurapwa ne insulin sezvinoratidzwa nekiriniki. Chirwere cheshuga chakaitika mu 0.3% (1/355) yevarwere vaigamuchira Opdualag, Giredhi 3 (0.3%) yakashata maitiro, uye hapana nyaya dzechirwere cheshuga ketoacidosis. Chirwere cheshuga hachina kutungamira mukuregedzwa zvachose kana kunyimwa kweOpdualag mune chero murwere.
Immune-Mediated Nephritis neRenal Dysfunction
Opdualag inogona kukonzera immune-mediated nephritis, iyo inotsanangurwa sekuda kushandiswa kwesteroids uye isina etiology yakajeka. Mune varwere vanogamuchira Opdualag, immune-mediated nephritis uye renal dysfunction yakaitika mu2% (7/355) yevarwere, kusanganisira Giredhi 3 (1.1%) uye Giredhi 2 (0.8%) maitiro asina kunaka. Immune-mediated nephritis uye kusashanda zvakanaka kwerenal kwakaita kuti Opdualag iregedze zvachose mu0.8% uye kunyimwa kweOpdualag mu0.6% yevarwere.
Kunyima kana kuregedza zvachose Opdualag zvichienderana nekuomarara (ndapota ona chikamu 2 Chiyero uye Kutonga mune inoperekedza Ruzivo Rwakazara rwekurongeka).
Immune-Mediated Dermatologic Yakashata Reaction
Opdualag inogona kukonzera immune-mediated rash kana dermatitis, inotsanangurwa sekuda kushandiswa kwesteroids uye pasina yakajeka imwe etiology. Exfoliative dermatitis, kusanganisira Stevens-Johnson syndrome, toxic epidermal necrolysis, uye Drug Rash ine eosinophilia uye systemic zviratidzo zvakaitika nePD-1/L-1 inovharira masoja ekudzivirira chirwere. Topical emollients uye/kana topical corticosteroids inogona kunge yakakwana kurapa zvinyoro kusvika pakati nepakati zvisina exfoliative rashes.
Kunyima kana kuregedza zvachose Opdualag zvichienderana nekuomarara (ndapota ona chikamu 2 Chiyero uye Kutonga mune inoperekedza Ruzivo Rwakazara rwekurongeka).
Immune-mediated rash yakaitika mu9% (33/355) yevarwere, kusanganisira Giredhi 3 (0.6%) uye Giredhi 2 (3.4%) maitiro akashata. Immune-mediated rash haina kutungamira mukuregedzwa zvachose kweOpdualag. Immune-mediated rash yakakonzera kunyimwa kweOpdualag mu1.4% yevarwere.
Immune-Mediated Myocarditis
Opdualag inogona kukonzera immune-mediated myocarditis, iyo inotsanangurwa sekuda kushandiswa kwesteroids uye pasina yakajeka imwe etiology. Kuongororwa kwe-immune-mediated myocarditis kunoda index yakakura yekufungira. Varwere vane cardiac kana cardio-pulmonary zviratidzo vanofanira kuongororwa kuti vangave myocarditis. Kana myocarditis ichifungidzirwa, rega dose, nokukurumidza tanga high dose steroids (prednisone kana methylprednisolone 1 kusvika 2 mg/kg/zuva) uye nokukurumidza ronga kubvunzurudza cardiology ne diagnostic workup. Kana zvakasimbiswa nekiriniki, rega zvachose Opdualag yeGiredhi 2-4 myocarditis.
Myocarditis yakaitika mu1.7% (6/355) yevarwere vanogamuchira Opdualag, kusanganisira Giredhi 3 (0.6%), uye Giredhi 2 (1.1%) maitiro akashata. Myocarditis yakatungamira kumisa zvachose Opdualag mu1.7% yevarwere.
Zvimwe Zviratidzo zveMune-Mediated zvakashata
Inotevera kliniki yakakosha IMARs yakaitika pane chiitiko che <1% (kunze kwekunge zvataurwa neimwe nzira) muvarwere vakagamuchira Opdualag kana vakashumwa nekushandiswa kweimwe PD-1 / PD-L1 inovharira masoja ekudzivirira. Mhosva dzakakomba kana dzinouraya dzakashumwa kune zvimwe zveizvi zvakaipira kuita: Cardiac/Vascular: pericarditis, vasculitis; Kutya Sisitimu: meningitis, encephalitis, myelitis uye demyelination, myasthenic syndrome/myasthenia gravis (kusanganisira kuwedzera), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; Ocular: uveitis, iritis, uye mamwe ocular kuzvimba toxicities zvinogona kuitika. Zvimwe zviitiko zvinogona kusanganiswa neretinal detachment. Magiredhi akasiyana-siyana ekukanganiswa kwekuona, kusanganisira upofu, anogona kuitika. Kana uveitis ikaitika pamwe chete nemamwe maIMAR, funga nezveVogt-Koyanagi-Harada-like syndrome, sezvo izvi zvingada kurapwa ne systemic steroids kuderedza dambudziko rekurasikirwa kwekuona zvachose; Zvemudumbu: pancreatitis inosanganisira kuwedzera serum amylase uye lipase mazinga, gastritis, duodenitis; Musculoskeletal uye Inobatanidza Tissue: myositis/polymyositis, rhabdomyolysis (uye zvakabatanidzwa zvinotevera zvinosanganisira renal kukundikana), arthritis, polymyalgia rheumatica; Endocrine: hypoparathyroidism; Zvimwe (Hematologic/Immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, kurambwa kwenhengo yakasimba.
Infusion-Yakabatana Maitiro
Opdualag inogona kukonzera yakakomba infusion-inoenderana nekuita. Regedza Opdualag muvarwere vane zvakakomba kana hupenyu-zvinotyisidzira infusion-zvine chekuita nekuita. Kukanganisa kana kuderedza chiyero chekuisa muvarwere vane zvinyoro-nyoro kusvika pakati nepakati-zvine chekuita nekupinza. Muvarwere vakagamuchira Opdualag semaminetsi makumi matanhatu intravenous infusion, maitiro ane chekuita neinfusion akaitika mu60% (7/23) yevarwere.
Matambudziko eAllogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Zvinouraya uye mamwe matambudziko akakomba anogona kuitika kune varwere vanogamuchira allogeneic hematopoietic stem cell transplantation (HSCT) vasati varapwa kana mushure mekurapwa nePD-1/PD-L1 receptor inovhara antibody. Matambudziko ane chekuita nekutapurirana anosanganisira hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive chirwere mushure mekuderedzwa kwesimba, uye steroid-inoda febrile syndrome (isina chikonzero chinotapukira). Aya matambudziko anogona kuitika kunyangwe kupindira kurapa pakati pePD-1/PD-L1 blockade uye allogeneic HSCT.
Tevedzera varwere zvakanyanya kune humbowo hwekuchinja-kune hukama uye pindira nekukasika. Funga kubatsirwa kwakatarisana nenjodzi dzekurapwa nePD-1/PD-L1 receptor inovharira antibody isati yasvika kana mushure meiyo allogeneic HSCT.
Embryo-Fetal Chefu
Zvichienderana nemaitiro ayo ekuita uye data kubva kuzvidzidzo zvemhuka, Opdualag inogona kukonzera kukuvara kwe "fetus" kana yapihwa kumukadzi ane nhumbu. Rairira vakadzi vane pamuviri nezvenjodzi inogona kuitika kumwana ari mudumbu. Rairira vakadzi vane mikana yekuzvara kuti vashandise kudzivirira kubata pamuviri kunoshanda panguva yekurapa neOpdualag kweinenge mwedzi mishanu mushure medoro rekupedzisira reOpdualag.
Kubata kumeso
Iko hakuna data pamusoro pekuvapo kweOpdualag mumukaka wemunhu, mhedzisiro pamwana anoyamwa, kana mhedzisiro pakugadzirwa kwemukaka. Nekuti nivolumab uye relatlimab inogona kuburitswa mumukaka wevanhu uye nekuda kwekugona kukanganisa kwakakomba mumwana anoyamwa, raira varwere kuti vasayamwisa panguva yekurapa neOpdualag uye kweinenge mwedzi mishanu mushure menguva yekupedzisira.
Kuita Kwakakomba Kwakaipa
MuRelativity-047, kuuraya kwakashata kwakaitika mu3 (0.8%) varwere vakabatwa neOpdualag; izvi zvaisanganisira hemophagocytic lymphohistiocytosis, acute edema yemapapu, uye pneumonitis. Kukanganisa kwakanyanya kwakaitika mu36% yevarwere vakarapwa neOpdualag. Zvakanyanya kuitika zvakakomba zvakashata zvakashumwa mu ≥1% yevarwere vakarapwa neOpdualag vaive adrenal insufficiency (1.4%), anemia (1.4%), colitis (1.4%), mabayo (1.4%), acute myocardial infarction (1.1%), kurwadziwa shure (1.1%), manyoka (1.1%), myocarditis (1.1%), uye pneumonitis (1.1%).
Common Adverse Reactions uye Laboratory Abnormalities
Maitiro akajairika akanyanya kutaurwa mu ≥20% yevarwere vakabatwa neOpdualag vaive kurwadziwa kwetsandanyama (45%), kuneta (39%), mapundu (28%), pruritus (25%), uye manyoka (24%).
Zvakanyanya kuitika murabhoritari zvisiri izvo zvakaitika mu ≥20% yevarwere vakarapwa neOpdualag vakaderedzwa hemoglobin (37%), yakaderera lymphocytes (32%), yakawedzera AST (30%), yakawedzera ALT (26%), uye yakadzikira sodium (24). %).
Please see U.S. Full Prescribing Information for Opdualag.
OPDIVO + YERVOY INDICATIONS
OPDIVO® (nivolumab), senhengo imwe chete, inoratidzirwa kurapwa kwevarwere vane unresectable kana metastatic melanoma.
OPDIVO® (nivolumab), pamwe neYERVOY® (ipilimumab), inoratidzirwa kurapwa kwevarwere vane unresectable kana metastatic melanoma.
OPDIVO + YERVOY ZVINOKOSHA RUZIVO RWEKUTEVHA
Yakakomba uye Inouraya Immune-Mediated Dzakashata Reaction
Maitiro ekudzivirira-epamuviri-akasangana akanyorwa pano anogona kusasanganisira zvese zvinokanganisa uye zvinouraya immune-mediated maitiro akashata.
Maitiro ekudzivirira-epamuviri, ayo anogona kunge akaomarara kana kuuraya, anogona kuitika mune chero nhengo yemuviri kana nyama. Nepo maitiro ekudzivirira anopindirana ne immune achiwanzo kuratidzwa panguva yekurapwa, anogona zvakare kuitika mushure mekumira kweOPDIVO kana YERVOY. Kuzivikanwa kwekutanga uye manejimendi zvakakosha kuti uone kushandiswa kwakachengeteka kweOPDIVO uye YERVOY. Chengetedza zviratidzo uye zviratidzo zvinogona kuve kiriniki kuratidzwa kwekukanganisa immune-mediated kusagadzikana kusagadzikana. Wongorora makiriniki emakemikari kusanganisira echiropa enzymes, creatinine, adrenocorticotropic hormone (ACTH), uye utachiona hunoshanda pakutanga uye nguva nenguva panguva yekurapwa neOPDIVO uye pamberi pega imwe yero yeJERVOY. Mune zviitiko zvekufungidzirwa kusagadzikana-kupindirana kusagadzikana kusagadzikana, tanga kukosheswa kwakaringana kusabvisa mamwe maitiro etiologies, kusanganisira hutachiona. Institute yekurapa manejimendi nekukurumidza, kusanganisira hunyanzvi kubvunza sezvakakodzera.
Ramba kana kurega zvachose OPDIVO uye YERVOY zvinoenderana nekuomarara (ndapota ona chikamu 2 Chipimo neHurumende mune inoenderana Inotungamira Ruzivo Ruzivo). Kazhinji, kana OPDIVO kana YERVOY kukanganiswa kana kuregedza kuchidikanwa, tora systemic corticosteroid therapy (1 kusvika 2 mg / kg / zuva prednisone kana yakaenzana) kusvika pakuvandudzika kusvika kuGiredhi 1 kana zvishoma. Pamusoro pekuvandudzika kusvika kuGiredhi 1 kana zvishoma, tanga corticosteroid taper uye ramba uchikanda pamusoro peinenge mwedzi mumwe. Funga nezve kutarisirwa kweimwe systemic immunosuppressants mune varwere vane immune-mediated maitiro akashata asingadzorwe nekorticosteroid kurapa. Hutungamiriri manejimendi manejimendi ekuchinja kwakashata ayo asingade systemic steroid (semuenzaniso, endocrinopathies uye dermatologic reaction) inokurukurwa pazasi.
Immune-Inopindirana Pneumonitis
OPDIVO neYERVOY zvinogona kukonzera immune-mediated pneumonitis. Chiitiko chepneumonitis chakakwira kune varwere vakambogamuchira musana wechipfuva. Mune varwere vanogamuchira OPDIVO monotherapy, immune-mediated pneumonitis yakaitika mu3.1% (61/1994) yevarwere, kusanganisira Giredhi 4 (<0.1%), Grade 3 (0.9%), uye Grade 2 (2.1%).
Muvarwere vanogamuchira OPDIVO 1 mg/kg neYERVOY 3 mg/kg mavhiki matatu oga oga, immune-mediated pneumonitis yakaitika mu3% (7/31) yevarwere, kusanganisira Grade 456 (4%), Grade 0.2 (3%), uye Grade 2.0 (2%).
Immune-Inopindirana Colitis
OPDIVO neYERVOY zvinogona kukonzera immune-mediated colitis, inogona kuuraya. Chiratidzo chakajairika chaisanganisirwa mutsanangudzo yecolitis yaive manyoka. Cytomegalovirus (CMV) utachiona / reactivation yakataurwa kune varwere vane corticosteroid-refractory immune-mediated colitis. Muzviitiko zve corticosteroid-refractory colitis, funga kudzokorora kushanda kwehutachiona kuti usasanganise mamwe etiologies. Muvarwere vanogamuchira OPDIVO monotherapy, immune-mediated colitis yakaitika mu2.9% (58/1994) yevarwere, kusanganisira Giredhi 3 (1.7%) uye Giredhi 2 (1%). Muvarwere vaigamuchira OPDIVO 1 mg/kg neYERVOY 3 mg/kg mavhiki matatu oga oga, immune-mediated colitis yakaitika mu3% (25/115) yevarwere, kusanganisira Grade 456 (4%), Grade 0.4 (3%) uye Giredhi. 14 (2%).
Immune-Inopindirana Hepatitis uye Hepatotoxicity
OPDIVO neYERVOY zvinogona kukonzera immune-mediated hepatitis. Muvarwere vaigamuchira OPDIVO monotherapy, immune-mediated hepatitis yakaitika mu1.8% (35/1994) yevarwere, kusanganisira Grade 4 (0.2%), Grade 3 (1.3%), uye Grade 2 (0.4%). Muvarwere vanowana OPDIVO 1 mg/kg neYERVOY 3 mg/kg mavhiki matatu oga oga, immune-mediated hepatitis yakaitika mu3% (15/70) yevarwere, kusanganisira Grade 456 (4%), Grade 2.4 (3%), uye Grade 11 (2%).
Immune-Inopindirana Endocrinopathies
OPDIVO neYERVOY zvinogona kukonzera kushomeka kwekutanga kana kwechipiri adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid zvinetso, uye Type 1 chirwere cheshuga mellitus, icho chinogona kuunza nechirwere cheshuga ketoacidosis. Ziva OPDIVO uye YERVOY zvinoenderana nekuomarara (ndapota ona chikamu 2 Chipimo neHurumende mune inoenderana Inotungamira Ruzivo Ruzivo). KweGiredhi 2 kana yepamusoro adrenal kusakwana, tanga kurapwa kwechiratidzo, kusanganisira kutsiva kwehomoni sekuratidzwa kwachiremba. Hypophysitis inogona kuuya nezviratidzo zvakakomba zvinosanganisirwa nehukuru hwekuita senge kutemwa nemusoro, photophobia, kana kutadza kuona mumunda. Hypophysitis inogona kukonzera hypopituitarism; tanga kutsiva mahormone sezvakaratidzirwa kuchipatara. Thyroiditis inogona kupa ne kana isina endocrinopathy. Hypothyroidism inogona kutevera hyperthyroidism; tanga kutsiviwa kwehormoni kana kurapwa sezvakaratidzirwa kuchipatara. Tarisa varwere vehyperglycemia kana zvimwe zviratidzo nezviratidzo zvechirwere cheshuga; tanga kurapwa ne insulin sezvakaratidzirwa kuchipatara.
Muvarwere vaiwana OPDIVO monotherapy, adrenal insufficiency yakaitika mu1% (20/1994), kusanganisira Grade 3 (0.4%) neGrade 2 (0.6%).Muvarwere vaiwana OPDIVO 1 mg/kg ne YERVOY 3 mg/kg masvondo matatu ega ega. , adrenal insufficiency yakaitika mu3% (8/35), kusanganisira Giredhi 456 (4%), Grade 0.2 (3%), uye Giredhi 2.4 (2%). Muvarwere vanogamuchira OPDIVO 4.2 mg/kg neYERVOY 1 mg/kg mavhiki matatu oga oga, adrenal insufficiency yakaitika mu3% (3/8), kusanganisira Giredhi 35 (456%), Grade 4 (0.2%), uye Grade 3 (2.4) %).
Mune varwere vanogamuchira OPDIVO monotherapy, hypophysitis yakaitika mu 0.6% (12/1994) yevarwere, kusanganisira Giredhi 3 (0.2%) uye Giredhi 2 (0.3%). Muvarwere vanogamuchira OPDIVO 1 mg/kg neYERVOY 3 mg/kg mavhiki matatu oga oga, hypophysitis yakaitika mu3% (9/42), kusanganisira Giredhi 456 (3%) uye Giredhi 2.4 (2%).
Mune varwere vanogamuchira OPDIVO monotherapy, thyroiditis yakaitika mu 0.6% (12/1994) yevarwere, kusanganisira Giredhi 2 (0.2%).
Mune varwere vanogamuchira OPDIVO monotherapy, hyperthyroidism yakaitika mu 2.7% (54/1994) yevarwere, kusanganisira Grade 3 (<0.1%) uye Grade 2 (1.2%). Muvarwere vanogamuchira OPDIVO 1 mg/kg neYERVOY 3 mg/kg mavhiki matatu oga oga, hyperthyroidism yakaitika mu3% (9/42) yevarwere, kusanganisira Giredhi 456 (3%) uye Giredhi 0.9 (2%).
Mune varwere vanogamuchira OPDIVO monotherapy, hypothyroidism yakaitika mu8% (163/1994) yevarwere, kusanganisira Giredhi 3 (0.2%) uye Giredhi 2 (4.8%). Muvarwere vanogamuchira OPDIVO 1 mg/kg neYERVOY 3 mg/kg mavhiki matatu oga oga, hypothyroidism yakaitika mu3% (20/91) yevarwere, kusanganisira Giredhi 456 (3%) uye Giredhi 0.4 (2%).
Mune varwere vanogamuchira OPDIVO monotherapy, chirwere cheshuga chakaitika mu 0.9% (17/1994) yevarwere, kusanganisira Giredhi 3 (0.4%) uye Grade 2 (0.3%), uye 2 kesi dzechirwere cheshuga ketoacidosis.
Immune-Mediated Nephritis neRenal Dysfunction
OPDIVO neYERVOY zvinogona kukonzera immune-mediated nephritis. Mune varwere vanogamuchira OPDIVO monotherapy, immune-mediated nephritis uye renal dysfunction yakaitika mu1.2% (23/1994) yevarwere, kusanganisira Giredhi 4 (<0.1%), Grade 3 (0.5%), uye Giredhi 2 (0.6%).
Immune-Mediated Dermatologic Yakashata Reaction
OPDIVO inogona kukonzeresa immune-Mediated mapundu kana dermatitis. Exfoliative dermatitis, inosanganisira Stevens-Johnson syndrome (SJS), chepfu epidermal necrolysis (TEN), uye kuputika kwezvinodhaka ne eosinophilia uye systemic zviratidzo (DRESS) yakaitika ne PD-1 / PD-L1 ichivharira antibodies. Misoro yepamusoro uye / kana topical corticosteroids inogona kukwana kurapa zvinyoro kusvika zvine mwero zvisina kufema.
YERVOY inogona kukonzera immune-mediated rash kana dermatitis, kusanganisira bullous uye exfoliative dermatitis, SJS, TEN, uye DRESS. Topical emollients uye/kana topical corticosteroids inogona kukwana kurapa zvinyoro-nyoro kusvika pakati nepakati zvisina-bullous/exfoliative rashes.
Ramba kana kurega zvachose OPDIVO uye YERVOY zvinoenderana nekuomarara (ndapota ona chikamu 2 Chipimo neHurumende mune inoenderana Inotungamira Ruzivo Ruzivo).
Mune varwere vanogamuchira OPDIVO monotherapy, kuputika kwekudzivirira kwekudzivirira kwakaitika mu9% (171/1994) yevarwere, kusanganisira Giredhi 3 (1.1%) uye Giredhi 2 (2.2%). Muvarwere vanogamuchira OPDIVO 1 mg/kg neYERVOY 3 mg/kg mavhiki matatu oga oga, kuputika kwekudzivirira kwekudzivirira kwakaitika mu3% (28/127) yevarwere, kusanganisira Grade 456 (3%) uye Grade 4.8 (2%).
Zvimwe Zviratidzo zveMune-Mediated zvakashata
Izvi zvinotevera zvinokonzeresa immune-mediated adverse reactions zvakaitika pachiitiko che <1% (kunze kwekunge zvataurwa neimwe nzira) muvarwere vakagamuchira OPDIVO monotherapy kana OPDIVO pamwe neYERVOY kana vakashumwa nekushandiswa kweimwe PD-1/PD-L1 inovharira. antibodies. Mhosva dzakakomba kana dzinouraya dzakashumwa nokuda kwezvimwe zvezviito izvi zvakashata: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis uye demyelination, myasthenic syndrome/myasthenia gravis (kusanganisira kuwedzera), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; maziso: uveitis, iritis, uye mamwe ocular kuzvimba toxicities zvinogona kuitika; gastrointestinal: pancreatitis inosanganisira kuwedzera kweserum amylase uye lipase mazinga, gastritis, duodenitis; musculoskeletal uye connective tishu: myositis/polymyositis, rhabdomyolysis, uye zvakabatanidzwa zvinotevera zvinosanganisira renal kukundikana, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; zvimwe (hematological/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, kurambwa kwenhengo yakasimba.
Pamusoro pemaitiro akashata ekudzivirira ekudzivirira akanyorwa pamusoro, pamiyedzo yekiriniki yeYERVOY monotherapy kana musanganiswa neOPDIVO, zvinotevera zvinokonzeresa zvakakosha zvekudzivirira-zvakaremara maitiro, zvimwe zvine mhedzisiro inouraya, zvakaitika mu <1% yevarwere kunze kwekunge zvataurwa neimwe nzira: nervous system: autoimmune neuropathy (2%), myasthenic syndrome / myasthenia gravis, kusagadzikana kwemotokari; moyo nevascular: angiopathy, temporal arteritis; maziso: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); zvimwe (hematological/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.
Mamwe machena macar kesi anogona kusanganiswa neretinal detachment. Mamakisi akasiyana siyana ekusaona zvakanaka, kusanganisira bofu, anogona kuitika. Kana uveitis ikaitika pamwe chete nekumwe kusapindirana kwekuzvidzivirira mumuviri, funga nezveVogt-Koyanagi-Harada-senge chirwere, icho chakaonekwa kune varwere vanogamuchira OPDIVO neYERVOY, sezvo izvi zvingangoda kurapwa ne systemic corticosteroids kudzikisa njodzi yekuona zvachose. kurasikirwa.
Infusion-Yakabatana Maitiro
OPDIVO neYERVOY zvinogona kukonzera zvakakomba infusion-inoenderana nekuita. Regedza OPDIVO neYERVOY muvarwere vane zvakanyanya (Giredhi 3) kana tyisidziro yehupenyu (Giredhi 4) infusion-inoenderana maitiro. Kuvhiringidza kana kuderedza chiyero chekuputira muvarwere vane hunyoro (Giredhi 1) kana mwero (Giredhi 2) maitiro ane chekuita nekupinza.
Muvarwere vanogamuchira OPDIVO monotherapy senge infusion yemaminetsi makumi matanhatu, maitiro ane chekuita nekupinza akaitika mu60% (6.4/127) yevarwere. Mune imwe muedzo wakasiyana umo varwere vakagamuchira OPDIVO monotherapy se 1994-minute infusion kana 60-minute infusion, infusion-inoenderana nekuita kwakaitika mu30% (2.2/8) uye 368% (2.7/10) yevarwere, zvichiteerana. Pamusoro pezvo, 369% (0.5/2) uye 368% (1.4/5) yevarwere, zvichiteerana, vakasangana neakaipa mukati memaawa makumi mana nemasere ekuisirwa izvo zvakaita kuti dose inonoke, kumiswa zvachose kana kunyimwa kweOPDIVO.
Mune varwere vemelanoma vanogamuchira OPDIVO 1 mg/kg neYERVOY 3 mg/kg mavhiki matatu oga oga, maitiro ane chokuita nekupinza akaitika mu3% (2.5/10) yevarwere.
Matambudziko eAllogeneic Hematopoietic Stem Cell Kuisazve
Zvinouraya uye zvimwe zvinetso zvakakomba zvinogona kuitika kune varwere vanogamuchira allogeneic hematopoietic stem cell transplantation (HSCT) isati yatanga kana mushure mekurapwa neOPDIVO kana YERVOY. Matambudziko ane chekuita nekudyara anosanganisira hyperacute graft-versus-host-chirwere (GVHD), acute GVHD, chisingaperi GVHD, hepatic veno-occlusive chirwere (VOD) mushure mekudzikiswa kwemamiriro ekunze, uye steroid-inoda febrile syndrome (isina chikonzero chinotapukira). Aya matambudziko anogona kuitika kunyangwe achipindira kurapwa pakati peOPDIVO kana YERVOY uye allogeneic HSCT.
Tevedza varwere padhuze nehumwe humbowo hwezvinetso zvine chekuita nekudyara uye pindira nekukurumidza. Funga zvakanakira maringe nenjodzi dzekurapwa neOPDIVO uye YERVOY pamberi kana mushure meiyo allogeneic HSCT.
Embryo-Fetal Chefu
Zvichienderana nemaitiro ayo ekuita uye zvakawanikwa kubva muzvidzidzo zvemhuka, OPDIVO neYERVOY zvinogona kukonzera kukuvadzwa kwe "fetus" kana yapihwa kumukadzi ane nhumbu. Mhedzisiro yeYERVOY inogona kunge yakakura panguva yechipiri neyechitatu trimesters yekuzvitakura. Rairira vakadzi vane pamuviri nezvenjodzi inogona kuitika kumwana ari mudumbu. Rairai vakadzi vane mikana yekuzvara kuti vashandise nzira dzekudzivirira nadzo pamuviri panguva yekurapa neOPDIVO neYERVOY uye kweinenge mwedzi mishanu mushure mekupihwa mushonga wekupedzisira.
Kuwedzera kwekufa muvarwere vane Multiple Myeloma apo OPDIVO yakawedzerwa kune Thalidomide Analogue uye Dexamethasone
Mune randomized kiriniki miedzo muvarwere vane multiple myeloma, kuwedzerwa kweOPDIVO kune thalidomide analogue pamwe nedexamethasone kwakakonzera kuwedzera kwekufa. Kurapa kwevarwere vane myeloma yakawanda ine PD-1 kana PD-L1 inodzivirira antibody pamwe ne thalidomide analogue pamwe ne dexamethasone haina kukurudzirwa kunze kwemakiriniki anodzorwa.
Kubata kumeso
Iko hakuna data pane hupo hweOPDIVO kana YERVOY mumukaka wemunhu, mhedzisiro pamwana anoyamwa, kana mhedzisiro mukugadzirwa kwemukaka. Nekuda kwekugona kwekukanganisa kwakakomba muvana vanoyamwiswa, raira vakadzi kuti vasayamwisa panguva yekurapwa uye kwemwedzi mishanu mushure mekupedzisira muyero.
Kuita Kwakakomba Kwakaipa
MuCheckmate 037, kukanganisa kwakakomba kwakaitika mu41% yevarwere vaigamuchira OPDIVO (n=268). Giredhi 3 uye 4 maitiro akashata akaitika mu42% yevarwere vanowana OPDIVO. Iyo inowanzogara Giredhi 3 uye 4 yakashata maitiro ezvinodhaka akashumwa mu2% kusvika <5% yevarwere vaigamuchira OPDIVO vaive marwadzo emudumbu, hyponatremia, yakawedzera aspartate aminotransferase, uye yakawedzera lipase. MuCheckmate 066, kukanganisa kwakakomba kwakaitika mu36% yevarwere vaigamuchira OPDIVO (n=206). Giredhi 3 uye 4 maitiro akashata akaitika mu41% yevarwere vanowana OPDIVO. Maitiro akanyanya eGiredhi 3 uye 4 akashata akataurwa mu ≥2% yevarwere vaigamuchira OPDIVO vaive gamma-glutamyltransferase kuwedzera (3.9%) uye manyoka (3.4%). MuCheckmate 067, kukanganisa kwakakomba (74% uye 44%), maitiro asina kunaka anotungamira kuregedzerwa zvachose (47% uye 18%) kana kunonoka dosing (58% uye 36%), uye Giredhi 3 kana 4 maitiro akashata (72% uye 51%) zvese zvakaitika kakawanda muOPDIVO plus YERVOY ruoko (n=313) zvine chekuita neruoko rweOPDIVO (n=313). Zvakanyanya kuitika (≥10%) zvakakomba maitiro akashata muOPDIVO plus YERVOY ruoko uye OPDIVO ruoko, zvakateerana, manyoka (13% uye 2.2%), colitis (10% uye 1.9%), uye pyrexia (10% uye 1.0). %).
Zvakajairika Zvakaipa Reaction
MuCheckmate 037, iyo yakajairika yakashata maitiro (≥20%) yakashumwa neOPDIVO (n=268) yaive rash (21%). MuCheckmate 066, maitiro akajairika akajairika (≥20%) akashumwa neOPDIVO (n = 206) vs dacarbazine (n = 205) aive kuneta (49% vs 39%), kurwadziwa musculoskeletal (32% vs 25%), rash. (28% vs 12%), uye pruritus (23% vs 12%). MuCheckmate 067, yakajairika (≥20%) maitiro akashata muOPDIVO pamwe neYERVOY ruoko (n=313) kwaive kuneta (62%), manyoka (54%), rash (53%), kusvotwa (44%), pyrexia (40%), pruritus (39%), marwadzo emusculoskeletal (32%), kurutsa (31%), kuderera kwechido (29%), chikosoro (27%), musoro (26%), dyspnea (24%), chepamusoro kufema turakiti chirwere (23%), arthralgia (21%), uye yakawedzera transaminases (25%). MuCheckmate 067, yakajairika (≥20%) maitiro asina kunaka muOPDIVO ruoko (n = 313) aive kuneta (59%), rash (40%), kurwadziwa kwemusculoskeletal (42%), manyoka (36%), kusvotwa. (30%), chikosoro (28%), pruritus (27%), utachiona hwepamusoro hwekufema (22%), kuderera kwechido (22%), musoro (22%), kuvimbiswa (21%), arthralgia (21%). , uye kurutsa (20%).
Please see US Full Prescribing Information for OPDIVO and YERVOY.
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Muna 2011, kuburikidza nechibvumirano chekubatana neOno Pharmaceutical Co., Bristol Myers Squibb yakawedzera kodzero dzenharaunda yekuvandudza nekutengesa. Wonderful pasi rose, kunze kwekuJapan, South Korea neTaiwan, uko Ono akange achengeta kodzero dzese kukomboni panguva iyoyo. Musi waChikunguru 23, 2014, Ono naBristol Myers Squibb vakawedzera chibvumirano chekubatana kwemakambani kuti vagadzirise pamwe nekutengesa ma immunotherapies akawanda - sevamiriri vega uye musanganiswa regimens - kune varwere vane cancer muJapan, South Korea neTaiwan.
Nezve 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 uye Juno Therapeutics vane makambani akazara e Bristol-Myers Squibb Company. Mune dzimwe nyika dziri kunze kweUS, nekuda kwemitemo yemuno, Celgene neJuno Therapeutics vanonzi, Celgene, kambani yeBristol Myers Squibb uye Juno Therapeutics, kambani yeBristol Myers Squibb.
Chiyeuchidzo Chirevo Nezve Pamberi-Kutarisa Zvirevo
Kuburitswa kwenhau uku kune "zvirevo zvinotarisa kumberi" mukati mezvinoreva Private Securities Litigation Reform Act ye1995 maererano, pakati pezvimwe zvinhu, kutsvagisa, kusimudzira uye kushambadzira kwezvigadzirwa zvemishonga. Zvese zvitaurwa zvisiri zvirevo zvezvakaitika kare ndezve, kana kuti zvinogona kunzi, zvirevo zvinomirira mberi. Matauriro akadaro anotarisa mberi anobva pane zvinotarisirwa uye fungidziro pamusoro pezvatichawana mune ramangwana rezvemari, zvinangwa, zvirongwa uye zvinangwa uye zvinosanganisira njodzi dzekuzvarwa, fungidziro uye kusava nechokwadi, zvinosanganisira zvemukati kana zvekunze zvinhu zvinogona kunonoka, kutsausa kana kushandura chero ipi zvayo mune inotevera. makore akati kuti, akaoma kufanotaura, anogona kunge asina simba redu uye anogona kukonzera mhedzisiro yemari yedu yeramangwana, zvinangwa, zvirongwa uye zvinangwa zvakasiyana kubva kune izvo zvinoratidzwa, kana zvinorehwa nezvitaurwa. Idzi njodzi, fungidziro, kusava nechokwadi uye zvimwe zvinhu zvinosanganisira, pakati pezvimwe, ingave OpdualagTM (nivolumab uye relatlimab-rmbw) ichabudirira mune zvekutengesa kune chiratidzo chakatsanangurwa mukuburitswa kwenhau, chero mvumo yekushambadzira, kana yakapihwa, inogona kunge iine mipimo mikuru pakushandisa kwavo, uye kuenderera mberi kwekubvumidzwa kwechigadzirwa chakadaro chechiratidzo chakatsanangurwa mupepanhau rino. kusunungurwa kunogona kuenderana nekusimbiswa uye kutsanangurwa kwekiriniki mabhenefiti mumiedzo yekusimbisa. Hapana chirevo chekutarisa mberi chinogona kuvimbiswa. Matauriro anotarisa mberi mune ino pepanhau anofanira kuongororwa pamwe chete nenjodzi dzakawanda uye kusava nechokwadi kunobata bhizinesi nemusika weBristol Myers Squibb, kunyanya izvo zvakaonekwa muyambiro uye nengozi yenhaurirano muBristol Myers Squibb's Annual Report paFomu 10-K ye. gore rakapera Zvita 31, 2021, sezvakagadziridzwa neinotevera Quarterly Reports paFomu 10-Q, Zvazvino Mishumo paFomu 8-K uye mamwe mafirita neSecurities and Exchange Commission. Zvinyorwa zvinotarisa mberi zvinosanganisirwa mugwaro rino zvinongoitwa kubva pazuva regwaro iri uye kunze kwekunge zvichidikanwa nemutemo unoshanda, Bristol Myers Squibb haasungirwe kuvandudza pachena kana kudzokorora chero chirevo chinomirira mberi, kungave semhedzisiro ruzivo rutsva, zviitiko zvenguva yemberi, mamiriro akachinja kana neimwe nzira.
References
- Opdualag Kunyora Ruzivo. Opdualag US Product Information. Yakagadziridzwa: Kurume 2022. Princeton, NJ: Bristol-Myers Squibb Company.
- Tawbi HA, Schadendorf D, Lipson EJ, et al. Relatlimab uye nivolumab versus nivolumab mune isina kurapwa advanced melanoma. N Engl J Med. 2022; 386: 24-34.
- Hodi FS, Chiarion-Sileni V, Gonzalez R, et al. Nivolumab pamwe ipilimumab kana nivolumab yega inopesana neipilimumab yega mune melanoma yepamusoro (CheckMate 067): 4-gore migumisiro ye multicentre, randomized, phase 3 muedzo. Lancet Oncol. 2018;19(11): 1480-1492.
- US Food & Drug Administration. Chaiyo-Nguva Oncology Ongorora Pilot Chirongwa.
