JANUARY 27, 2023-Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), wani kamfani na kimiyyar halittu na duniya da ke haɓaka, masana'antu da kuma sayar da hanyoyin kwantar da hankali don magance cututtuka masu barazana ga rayuwa, ya sanar a yau cewa CARTITUDE-4, nazarin Phase 3 yana kimanta CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) don kula da tsofaffi marasa lafiya tare da sake dawowa da kuma lenalidomide-refractory multiple myeloma, ya sadu da farkon ƙarshen ƙarshensa na nuna ci gaba mai mahimmanci a cikin rayuwa marar ci gaba (PFS) idan aka kwatanta da daidaitattun jiyya a farkon bincike na wucin gadi na binciken. . Binciken ya kasance ba a rufe ba bayan shawarar kwamitin sa ido kan bayanai mai zaman kansa.
Nazarin CARTITUDE-4 (NCT04181827) shine na farko na kasa da kasa, bazuwar, binciken buɗaɗɗen lakabin Phase 3 wanda ke kimanta inganci da amincin maganin CAR-T tare da pomalidomide, bortezomib da dexamethasone (PVd) ko daratumumab, pomalidomide da dexamethasone (DP) a cikin manya marasa lafiya tare da relapsed da lenalidomide-refractory mahara myeloma wanda ya karbi daya zuwa uku kafin layi na far.
Babban ƙarshen binciken shine PFS. Ƙarshen ƙarshe na biyu sun haɗa da aminci, rayuwa gabaɗaya (OS), ƙarancin ƙarancin cuta (MRD) ƙimar mara kyau da ƙimar amsa gabaɗaya (ORR). Za a ci gaba da bin marasa lafiya don matakin farko da na biyu a matsayin wani ɓangare na binciken CARTITUDE-4.
"Magungunan CAR-T mai sarrafa kansa yana wakiltar babban ci gaba a cikin maganin ciwon daji, kuma sakamakon mafi girma daga CARTITUDE-4 yana goyan bayan ci gaba da ƙoƙarinmu na kawo wannan zaɓin magani ga marasa lafiya. Multi myeloma a cikin matakai daban-daban na ci gaban cututtuka, "in ji Lida Pacaud, MD, Mataimakin Shugaban Cibiyar Ci Gaban Ci Gaban Clinical da Harkokin Kiwon Lafiya a Legend Biotech.
Sakamako daga binciken CARTITUDE-4 za a ƙaddamar da shi zuwa taron likita mai zuwa kuma zai goyi bayan tattaunawa da hukumomin kiwon lafiya game da yuwuwar ƙaddamar da tsari.
CARVYKTI® ALAMOMIN DA AMFANI
CARVYKTI® (ciltacabtagene autoleucel) antigen ne B-cell maturation antigen (BCMA) wanda aka canza ta tantanin halitta T tantanin halitta immunotherapy An nuna don kula da tsofaffi marasa lafiya tare da relapsed ko refractory mahara myeloma, bayan hudu ko fiye kafin Lines na far, ciki har da proteasome inhibitor, immunomodulatory wakili, da anti-CD38 monoclonal antibody.
WARNINGS DA ZUWA
CYTOKINE SAKI SYNDROME (CRS) ciki har da halayen mutuwa ko masu barazanar rai, sun faru bayan jiyya tare da CARVYKTI® a cikin 95% (92/97) na marasa lafiya da ke karɓar ciltacabtagene autoleucel. Mataki na 3 ko mafi girma CRS (2019 ASTCT grade) ya faru a cikin 5% (5/97) na marasa lafiya, tare da Grade 5 CRS da aka ruwaito a cikin majiyyaci 1. Tsakanin lokacin fara CRS shine kwanaki 7 (kewaye: kwanaki 1-12). Mafi yawan bayyanar cututtuka na CRS sun hada da pyrexia (100%), hypotension (43%), karuwar aspartate aminotransferase (AST) (22%), sanyi (15%), ƙarar alanine aminotransferase (ALT) (14%) da sinus tachycardia (sinus tachycardia). 11%). Matsayi na 3 ko abubuwan da suka fi girma da suka shafi CRS sun haɗa da ƙarar AST da ALT, hyperbilirubinemia, hypotension, pyrexia, hypoxia, gazawar numfashi, mummunan rauni na koda, watsawa na intravascular coagulation, HLH / MAS, angina pectoris, supraventricular da ventricular tachycardia, malaise, myalgias, ya karu. C-reactive protein, ferritin, alkaline phosphatase na jini da gamma-glutamyl transferase.
Gano CRS bisa ga gabatarwar asibiti. Yi la'akari da kuma magance wasu abubuwan da ke haifar da zazzabi, hypoxia, da hypotension. An ba da rahoton cewa CRS yana da alaƙa da binciken HLH/MAS, kuma ilimin ilimin halittar ɗan adam na iya haɗuwa. HLH/MAS yanayi ne mai yuwuwar barazanar rayuwa. A cikin marasa lafiya tare da alamun ci gaba na CRS ko CRS mai juyayi duk da jiyya, kimantawa don shaidar HLH/MAS.
Sittin da tara na 97 (71%) marasa lafiya sun karɓi tocilizumab da/ko corticosteroid don CRS bayan jiko na ciltacabtagene autoleucel. Marasa lafiya arba'in da huɗu (45%) sun karɓi tocilizumab kawai, wanda 33 (34%) sun karɓi kashi ɗaya kuma 11 (11%) sun karɓi fiye da kashi ɗaya; 24 marasa lafiya (25%) sun karbi tocilizumab da corticosteroid, kuma daya mai haƙuri (1%) ya karbi kawai corticosteroids. Tabbatar cewa ana samun mafi ƙarancin allurai biyu na tocilizumab kafin jiko na CARVYKTI.®.
Kula da marasa lafiya aƙalla kowace rana na kwanaki 10 bayan CARVYKTI® jiko a wurin kiwon lafiya da aka tabbatar da REMS don alamu da alamun CRS. Kula da marasa lafiya don alamun ko alamun CRS na akalla makonni 4 bayan jiko. A farkon alamar CRS, nan da nan kafa jiyya tare da kulawar tallafi, tocilizumab, ko tocilizumab da corticosteroids.
Shawarci marasa lafiya da su nemi kulawar likita nan take ya kamata alamu ko alamun CRS su faru a kowane lokaci.
CUTAR JINI, wanda zai iya zama mai tsanani, mai barazanar rai ko mai kisa, ya faru bayan jiyya tare da CARVYKTI®. Abubuwan da ke haifar da cutar neurologic sun haɗa da ICANS, ƙwayar cuta ta neurologic tare da alamu da alamun cututtukan Parkinsonism, Guillain-Barré Syndrome, neuropathies na gefe, da ciwon jijiyoyi na cranial. Nasiha ga majiyyata akan alamomi da alamun waɗannan cututtukan cututtukan jijiya, da kuma jinkirin farawar wasu daga cikin waɗannan gubar. Umurci marasa lafiya da su nemi kulawar likita nan da nan don ƙarin ƙima da gudanarwa idan alamu ko alamun kowane ɗayan waɗannan cututtukan ƙwayoyin cuta sun faru a kowane lokaci.
Gabaɗaya, ɗaya ko fiye da nau'ikan cututtukan cututtukan ƙwayoyin cuta da aka bayyana a ƙasa sun faru bayan ciltacabtagene autoleucel a cikin 26% (25/97) na marasa lafiya, wanda 11% (11/97) na marasa lafiya sun sami digiri na 3 ko abubuwan da suka fi girma. An kuma lura da waɗannan nau'o'in nau'ikan cututtukan neurologic a cikin binciken guda biyu masu gudana.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Marasa lafiya na iya fuskantar ICANS mai kisa ko mai barazanar rai bayan jiyya tare da CARVYKTI®, ciki har da kafin fara CRS, tare da CRS, bayan ƙudurin CRS, ko kuma in babu CRS. ICANS ya faru a cikin 23% (22/97) na marasa lafiya da ke karɓar ciltacabtagene autoleucel ciki har da abubuwan da suka faru na Grade 3 ko 4 a cikin 3% (3/97) da Grade 5 (masu mutuwa) a cikin 2% (2/97). Matsakaicin lokacin fara ICANS shine kwanaki 8 (kewayon kwanaki 1-28). Duk marasa lafiya 22 da ke da ICANS suna da CRS. Mafi yawan bayyanar (≥5%) na ICANS sun haɗa da encephalopathy (23%), aphasia (8%) da ciwon kai (6%).
Kula da marasa lafiya aƙalla kowace rana na kwanaki 10 bayan CARVYKTI® jiko a cibiyar kiwon lafiya ta REMS don alamu da alamun ICANS. Kashe wasu dalilai na alamun ICANS. Kula da marasa lafiya don alamun ko alamun ICANS na akalla makonni 4 bayan jiko kuma a yi magani da sauri. Ya kamata a gudanar da ƙwayar cutar ta jiki tare da kulawa mai tallafi da / ko corticosteroids kamar yadda ake bukata.
Parkinsonism: Daga cikin marasa lafiya na 25 a cikin binciken CARTITUDE-1 da ke fuskantar kowane nau'in neurotoxicity, marasa lafiya maza biyar suna da cututtukan neurologic tare da alamu da alamun bayyanar cututtuka na parkinsonism, daban-daban daga ciwon ƙwayar cutar neurotoxicity (ICANS). An ba da rahoton ciwon jijiyoyi tare da parkinsonism a cikin wasu gwaje-gwajen da ke gudana na ciltacabtagene autoleucel. Marasa lafiya suna da alamun cututtukan Parkinsonian da waɗanda ba na parkinsonian waɗanda suka haɗa da rawar jiki, bradykinesia, motsi na son rai, stereotypy, asarar motsi na kwatsam, abin rufe fuska, rashin tausayi, tasiri mai lebur, gajiya, tauri, jinkirin psychomotor, micrographia, dysgraphia, apraxia, lethargy, rudani, somnotypy , Rashin hankali, jinkirin ra'ayi, hyperreflexia, asarar ƙwaƙwalwar ajiya, wahalar haɗiye, rashin daidaituwa na hanji, fadowa, matsananciyar matsayi, karkatarwa gait, rauni na tsoka da ɓata, rashin aikin motsa jiki, motar motsa jiki da hasara mai hankali, akinetic mutism, da alamun sakin gaba na lobe. Matsakaicin farawa na parkinsonism a cikin marasa lafiya 5 a cikin CARTITUDE-1 shine kwanaki 43 (kewayon 15-108) daga jiko na ciltacabtagene autoleucel.
Kula da marasa lafiya don alamun da alamun fakinsonism waɗanda ƙila a jinkirta farawa kuma ana sarrafa su tare da matakan kulawa. Akwai taƙaitaccen bayanin inganci tare da magungunan da ake amfani da su don maganin cutar ta Parkinson, don haɓakawa ko warware alamun cututtukan parkinsonism bayan CARVYKTI® Magani.
Ciwon Guillain-Barré: Wani sakamako mai muni da ke biye da ciwon Guillain-Barré (GBS) ya faru a wani binciken ci gaba da ci gaba da ci gaba da ciltacabtagene autoleucel duk da jiyya tare da immunoglobulins na ciki. Alamomin da aka ruwaito sun haɗa da waɗanda suka yi daidai da bambancin Miller-Fisher na GBS, ƙwaƙwalwar ƙwaƙwalwa, raunin motsi, damuwa da magana da polyradiculoneuritis.
Saka idanu don GBS. Yi la'akari da marasa lafiya da ke nunawa tare da neuropathy na gefe don GBS. Yi la'akari da jiyya na GBS tare da matakan kulawa na tallafi da haɗin gwiwa tare da immunoglobulins da musayar jini, dangane da tsananin GBS.
Neuropathy na Peripheral: Marasa lafiya shida a cikin CARTITUDE-1 sun haɓaka neuropathy na gefe. Waɗannan cututtukan neuropathy waɗanda aka gabatar a matsayin masu jijiyoyi, motsa jiki ko na'urori masu jijiyoyi. Matsakaicin lokacin fara bayyanar cututtuka shine kwanaki 62 (kewayon kwanaki 4-136), tsawon lokaci na tsaka-tsakin neuropathy na gefe shine kwanaki 256 (kewayon 2-465 kwanaki) ciki har da waɗanda ke da neuropathy mai gudana. Marasa lafiya waɗanda suka ɗanɗana neuropathy na gefe suma sun sami ciwon jijiyoyi na cranial ko GBS a cikin wasu gwaje-gwajen da ke gudana na ciltacabtagene autoleucel.
Cranial Nerve Palsies: Marasa lafiya uku (3.1%) sun sami ciwon jijiyoyi na cranial a cikin CARTITUDE-1. Dukkanin marasa lafiya guda uku suna da ciwon jijiyoyi na cranial na 7; daya majiyyaci yana da 5th cranial jijiya palsy kuma. Matsakaicin lokacin farawa shine kwanaki 26 (kewayon kwanaki 21-101) bayan jiko na ciltacabtagene autoleucel. Ya faru na 3rd da 6th cranial jijiyar jijiyoyi, na biyu na 7th cranial jijiyar jijiyar jijiyoyi, daɗaɗɗen jijiyar jijiyar cranial bayan ingantawa, da kuma abin da ya faru na ƙananan ƙwayoyin cuta a cikin marasa lafiya da ciwon daji na cranial kuma an ruwaito su a cikin gwajin ci gaba na ciltacabtagene autoleucel. Kula da marasa lafiya don alamun da alamun cututtukan jijiyoyi na cranial. Yi la'akari da gudanarwa tare da tsarin corticosteroids, dangane da tsanani da ci gaban alamu da bayyanar cututtuka.
LITTAFI MAI TSARKI (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): M HLH ya faru a cikin majiyyaci ɗaya (1%), kwanaki 99 bayan ciltacabtagene autoleucel. An gabatar da taron HLH da tsawaitawar CRS na kwanaki 97. Abubuwan da ke nuna HLH/MAS sun haɗa da hawan jini, hypoxia tare da lalata alveolar lalacewa, coagulopathy, cytopenia, da rashin aiki mai yawa, ciki har da rashin aikin koda. HLH yanayi ne mai barazanar rai tare da yawan mace-mace idan ba a gane shi ba kuma a yi masa magani da wuri. Ya kamata a gudanar da jiyya na HLH/MAS bisa ga ƙa'idodin hukumomi.
CARVYKTI® REMS: Saboda haɗarin CRS da ƙwayoyin cuta na neurologic, CARVYKTI® yana samuwa ne kawai ta hanyar ƙayyadaddun shirin a ƙarƙashin Ƙididdigar Haɗari da Dabarun Rage Ragewa (REMS) mai suna CARVYKTI® REMS.
CYTOPENIAS MAI YAWA DA YAWAMarasa lafiya na iya nuna tsawaitawa da maimaita cytopenia bin lymphodepleting chemotherapy da CARVYKTI® jiko. Ɗaya daga cikin majiyyaci ya yi maganin ƙwayar ƙwayar cuta ta autologous don gyaran hematopoietic saboda tsawan lokaci thrombocytopenia.
A cikin CARTITUDE-1, 30% (29/97) na marasa lafiya sun sami dogon lokaci na Grade 3 ko 4 neutropenia da 41% (40/97) na marasa lafiya sun sami tsawan Grade 3 ko 4 thrombocytopenia wanda ba a warware ta ranar 30 bayan cittacabtagene autoleucel jiko.
Maimaitawa Grade 3 ko 4 neutropenia, thrombocytopenia, lymphopenia da anemia an gani a 63% (61/97), 18% (17/97), 60% (58/97), da 37% (36/97) bayan murmurewa daga Farko na 3 ko 4 cytopenia bayan jiko. Bayan Rana ta 60 biyo bayan jiko na ciltacabtagene autoleucel, 31%, 12% da 6% na marasa lafiya sun sake dawowa na Grade 3 ko mafi girma lymphopenia, neutropenia da thrombocytopenia, bi da bi, bayan an fara dawo da cytopenia na Grade 3 ko 4. Kashi tamanin da bakwai (84/97) na marasa lafiya sun sami maimaitawa ɗaya, biyu, ko uku ko fiye na cytopenia na Grade 3 ko 4 bayan farkawa na cytopenia na Grade 3 ko 4. Marasa lafiya shida da 11 sun sami Grade 3 ko 4 neutropenia da thrombocytopenia, bi da bi, a lokacin mutuwa.
Kula da ƙididdigar jini kafin da bayan CARVYKTI® jiko. Sarrafa cytopenia tare da abubuwan haɓakawa da tallafin ƙarin ƙarin jini bisa ga jagororin cibiyoyi na gida.
CUTUTTUKA: CARVYKTI® bai kamata a gudanar da shi ga marasa lafiya tare da kamuwa da cuta mai aiki ko cututtuka masu kumburi ba. Mummunan cututtuka masu haɗari, masu haɗari ko haɗari sun faru a cikin marasa lafiya bayan CARVYKTI® jiko.
Cututtuka (duk maki) sun faru a cikin marasa lafiya 57 (59%). Kwayoyin cututtuka na 3 ko 4 sun faru a cikin 23% (22/97) na marasa lafiya; Kwayoyin cututtuka na digiri 3 ko 4 tare da kwayoyin cutar da ba a bayyana ba sun faru a cikin 17%, cututtuka na hoto a cikin 7%, cututtuka na kwayoyin cuta a cikin 1%, da cututtukan fungal a cikin 1% na marasa lafiya. Gabaɗaya, marasa lafiya huɗu suna da cututtukan Grade 5: ƙurar huhu (n=1), sepsis (n=2) da ciwon huhu (n=1).
Kula da marasa lafiya don alamun da alamun kamuwa da cuta kafin da bayan CARVYKTI® jiko da kuma kula da marasa lafiya yadda ya kamata. Gudanar da prophylactic, pre-emptive da/ko magungunan kashe kwayoyin cuta bisa ga daidaitattun jagororin cibiyoyi. An lura da neutropenia na Febrile a cikin 10% na marasa lafiya bayan jiko na ciltacabtagene autoleucel, kuma yana iya kasancewa tare da CRS. A cikin yanayin neutropenia na febrile, ƙididdige kamuwa da cuta kuma sarrafa tare da maganin rigakafi masu yawa, ruwaye da sauran kulawar tallafi, kamar yadda likita ya nuna.
Maimaita Kwayar cuta: Maimaita cutar Hepatitis B (HBV), a wasu lokuta yana haifar da fulminant hepatitis, gazawar hanta da mutuwa, na iya faruwa a cikin marasa lafiya da hypogammaglobulinemia. Yi bincike don Cytomegalovirus (CMV), HBV, cutar hanta C (HCV), da ƙwayar cuta ta rigakafi ta mutum (HIV), ko duk wani nau'in cututtuka idan an nuna su ta asibiti daidai da jagororin asibiti kafin tarin sel don masana'antu. Yi la'akari da maganin ƙwayar cuta don hana sake kunnawa ta hoto ta hanyar jagororin cibiyoyi na gida/aiki na asibiti.
HYPOGAMMAGLOBULINEMIA an bayar da rahoton a matsayin mummunan lamari a cikin 12% (12/97) na marasa lafiya; Matakan IgG na dakin gwaje-gwaje sun faɗi ƙasa da 500 mg/dL bayan jiko a cikin 92% (89/97) na marasa lafiya. Kula da matakan immunoglobulin bayan jiyya tare da CARVYKTI® da kuma gudanar da IVIG don IgG <400 mg/dL. Sarrafa kowane jagororin cibiyoyi na gida, gami da rigakafin kamuwa da cuta da ƙwayoyin cuta ko rigakafi na rigakafi.
Amfani da Alurar Rayayyun: Amintaccen rigakafin rigakafi tare da allurar rigakafi masu rai yayin ko bin CARVYKTI® ba a yi nazarin magani ba. Ba a ba da shawarar yin allurar rigakafin ƙwayoyin cuta masu rai na aƙalla makonni 6 kafin fara aikin chemotherapy na lymphodepleting, yayin CARVYKTI.® jiyya, kuma har sai an dawo da rigakafi bayan jiyya tare da CARVYKTI®.
MALAMAN HANKALI sun faru a cikin 5% (5/97) na marasa lafiya biyo bayan jiko na ciltacabtagene autoleucel. Mummunan halayen hawan jini, gami da anaphylaxis, na iya kasancewa saboda dimethyl sulfoxide (DMSO) a cikin CARVYKTI®. Ya kamata a kula da marasa lafiya a hankali na tsawon sa'o'i 2 bayan jiko don alamun da bayyanar cututtuka mai tsanani. Yi magani da sauri kuma sarrafa yadda ya kamata bisa ga tsananin rashin jin daɗi.
MALALA NA BIYU: Marasa lafiya na iya haɓaka malignancies na biyu. Kula da tsawon rayuwa don rashin lafiya na biyu. Idan rashin lafiya ta biyu ta faru, tuntuɓi Janssen Biotech, Inc., a 1-800-526-7736 don bayar da rahoto da kuma samun umarni game da tarin samfuran haƙuri don gwaji na rashin lafiya na biyu na asalin T cell.
ILLOLI AKAN RASHIN YIN TUKA DA AMFANI DA NA'URA: Saboda yuwuwar abubuwan da ke faruwa na neurologic, gami da canjin yanayin tunani, rikice-rikice, raguwar neurocognitive, ko neuropathy, marasa lafiya suna cikin haɗari don canzawa ko rage hankali ko daidaitawa a cikin makonni 8 da ke bin CARVYKTI.® jiko. Shawartar marasa lafiya da su guji tuƙi da shiga ayyuka masu haɗari ko ayyuka, kamar aiki da nauyi ko yuwuwar injuna a wannan lokacin na farko, da kuma yayin da sabon farkon kowane cututtukan cututtukan neurologic.
SHA'AWAR SHA'AWA
Mafi yawan abubuwan da ba a cikin dakin gwaje-gwaje ba (abin da ya faru fiye da 20%) shine pyrexia, ciwon saki na cytokine, hypogammaglobulinemia, hypotension, zafi na musculoskeletal, gajiya, cututtuka na pathogen da ba a bayyana ba, tari, sanyi, zawo, tashin zuciya, encephalopathy, rage yawan ci. ciwon kai, tachycardia, dizziness, dyspnea, edema, viral cututtuka, coagulopathy, maƙarƙashiya, da amai. Mafi yawan halayen halayen dakin gwaje-gwaje (abin da ya fi girma ko daidai da 50%) sun haɗa da thrombocytopenia, neutropenia, anemia, hawan aminotransferase, da hypoalbuminemia.
CAR T-Cell far yana daga cikin hanyoyin magance wasu nau'ikan cututtukan daji na jini. Akwai fiye da 750 da ke gudana gwaji na asibiti in CAR T-Cell far a China a halin yanzu. Marasa lafiya waɗanda ke son yin rajista za su iya tuntuɓar su Faxar Cancer Layin taimakon marasa lafiya akan WhatsApp + 91 96 1588 1588 ko imel zuwa info@cancerfax.com.
Da fatan za a karanta cikakken Adana Bayani gami da Gargadin Akwati don CARVYKTI®.
GAME CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)
Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells. The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.[1]
A cikin Disamba 2017, Legend Biotech ya shiga cikin keɓantaccen lasisi na duniya da yarjejeniyar haɗin gwiwa tare da Janssen Biotech, Inc. (Janssen) don haɓakawa da tallata cilta-cel.
A cikin Fabrairu 2022, Cibiyar Abinci da Magunguna ta Amurka (FDA) ta amince da cilta-cel a ƙarƙashin sunan alamar CARVYKTI® don kula da manya tare da sake dawo da myeloma da yawa. A cikin Mayu 2022, Hukumar Tarayyar Turai (EC) ta ba da izinin tallace-tallace na sharadi na CARVYKTI® don kula da manya tare da sake dawowa da maƙarƙashiyar myeloma mai yawa.[3] A cikin Satumba 2022, Ma'aikatar Lafiya, Ma'aikata da Jin Dadin Jama'a (MHLW) ta amince da CARVYKTI®.[4] An ba Cilta-cel lambar yabo ta Breakthrough Therapy a Amurka a cikin Disamba 2019 da kuma a China a cikin Agusta 2020. Bugu da ƙari, cilta-cel ta karɓi nadi na PRIority Medicines (PRIME) daga Hukumar Turai a cikin Afrilu 2019. Cilta-cel kuma ta karɓi Marayu Drug Zayyana daga FDA ta Amurka a cikin Fabrairu 2019, daga Hukumar Turai a watan Fabrairu 2020, da kuma daga Hukumar Magunguna da Magunguna (PMDA) a Japan a cikin Yuni 2020. A cikin Maris 2022, Kwamitin Magungunan Magunguna na Turai don Kayayyakin Magunguna Marayu ya ba da shawarar ta hanyar yarjejeniya cewa za a ci gaba da sanya sunan marayu don cilta-cel bisa ga bayanan asibiti da ke nuna ingantacciyar ƙimar amsawa da ci gaba bayan jiyya.
GAME DA YAWA MYELOMA
Multiple myeloma ba shi da magani cutar kansa wanda ke farawa a cikin kasusuwan kasusuwa kuma yana nuna yawan yaduwa na ƙwayoyin plasma. A cikin 2023, an kiyasta cewa fiye da mutane 35,000 za su kamu da cutar myeloma mai yawa, kuma fiye da mutane 12,000 za su mutu daga cutar a Amurka Yayin da wasu marasa lafiya da ke da myeloma da yawa ba su da alamun cutar kwata-kwata, yawancin marasa lafiya ana gano su saboda alamun bayyanar. wanda zai iya haɗa da matsalolin kashi, ƙarancin ƙididdiga na jini, hawan calcium, matsalolin koda ko cututtuka.[8]. Ko da yake jiyya na iya haifar da gafara, abin takaici, marasa lafiya za su iya komawa baya. Marasa lafiya waɗanda suka koma bayan jiyya tare da daidaitattun hanyoyin kwantar da hankali, gami da masu hana protease, wakilai na immunomodulatory, da anti-CD38 monoclonal antibody, suna da ƙarancin tsinkaya da zaɓuɓɓukan magani kaɗan.
[1] CARVYKTI™ Bayanin Rubutu. Horsham, PA: Janssen Biotech, Inc.
[2] CARVYKTI™ (ciltacabtagene autoleucel), BCMA-Directed CAR-T Therapy, Ya Karɓi Amincin FDA na Amurka don Kula da Marasa lafiya Manya tare da Mai Rarraba ko Mai Rarraba Multiple Myeloma. Akwai a: https://legendbiotech.com/legend-news/carvykti-ciltacabtagene-autoleucel-bcma-directed-car-t-therapy-receives-us-fda-approval-for-the-treatment-of-adult-patients -tare da sake dawowa-ko-refractory-multiple-myeloma/. An shiga Oktoba 2022.
[3] CARVYKTI (ciltacabtagene autoleucel) Ƙaddamar da Yarjejeniyar Sharuɗɗa ta Hukumar Turai don Kula da Marasa lafiya tare da Maimaitawa da Mai Rarraba Multiple Myeloma. Akwai a: https://legendbiotech.com/legend-news/carvykti-ciltacabtagene-autoleucel-granted-conditional-approval-by-the-european-commission-for-the-treatment-of-patients-with-relapsed-and -refractory-multiple-myeloma/. An shiga Oktoba 2022.
[4] CARVYKTI ™ (ciltacabtagene autoleucel) Ya Karɓi Amincewa daga Ma'aikatar Lafiya, Ma'aikata da Jin Dadin Jama'a (MHLW) don Kula da Marasa lafiya tare da Mai Rarraba Mai Rarraba ko Refractory Multiple Myeloma. Akwai a: https://www.businesswire.com/news/home/20220926005847/en/CARVYKTI%E2%84%A2-ciltacabtagene-autoleucel-Receives-Approval-from-Japan%E2%80%99s-Ministry-of -Labour-Labour-da-Welfare-MHLW-don-maganin-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-masu-Myeloma. An shiga Oktoba 2022.
[5] Hukumar Tarayyar Turai. Rijistar Al'umma na Kayayyakin Magungunan Marayu. Akwai a: https://ec.europa.eu/health/documents/community-register/html/o2252.htm. An shiga Oktoba 2022.
[6] Ƙungiyar Amirka na Clinical Oncology. Multiple myeloma: gabatarwa. https://www.cancer.net/cancer-types/multiple-myeloma/introduction. An shiga Oktoba 2022.
[7] Ƙungiyar Ciwon Kankara ta Amirka. "Kididdigar Maɓalli Game da Multiple Myeloma." Akwai a: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men%20and%2015%2C370% 20 cikin% 20 mata). An shiga Janairu 2023.
[8] Ƙungiyar Ciwon Kankara ta Amirka. Multiple myeloma: ganewar farko, ganewar asali da tsari. https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. An shiga Oktoba 2022.
[9] Rajkumar SV. Multiple myeloma: Sabunta 2020 akan ganewar asali, haɗarin haɗari da gudanarwa. Ina J Hematol. 2020;95 (5), 548-567. doi:10.1002/ajh.25791.
[10] Kumar SK, Dimopoulos MA, Kastritis E, et al. Tarihin halitta na sake dawowa myeloma, mai juyayi zuwa magungunan immunomodulatory da masu hana proteasome: nazarin IMWG da yawa. Cutar sankarar bargo. 2017;31 (11):2443- 2448.
[11] Gandhi UH, Cornell RF, Lakshman A, et al. Sakamakon marasa lafiya tare da myeloma mai yawa refractory zuwa CD38-niyya na monoclonal antibody far. Cutar sankarar bargo. 2019;33 (9):2266-2275.
GAME DA LEGEND BIOTECH
Legend Biotech kamfani ne na kimiyyar halittu na duniya wanda aka sadaukar don yin magani, da kuma warkar da cututtuka masu barazana ga rayuwa wata rana. Wanda ke da hedikwata a Somerset, New Jersey, muna haɓaka ci-gaba na hanyoyin kwantar da tarzoma a cikin nau'ikan dandamali na fasaha, gami da autologous da allogeneic chimeric antigen receptor T-cell, gamma-delta T cell (gd T) da kuma na halitta kisa (NK) tushen cell. immunotherapy. Daga rukunin yanar gizon mu na R&D guda uku a duk duniya, muna amfani da waɗannan sabbin fasahohin don bin diddigin gano lafiya, inganci da manyan hanyoyin warkewa ga marasa lafiya a duk duniya.
