Sebtembar 6, 2021, JW Therapeutics waxay ku dhawaaqday in Maamulka Badeecadaha Caafimaadka Qaranka (NMPA) ee Shiinaha uu ansixiyay Codsiga Daawada Cusub (NDA) ee daawada anti-CD19 ee autologous chimeric antigen receptor T (CAR-T) ee relmacabtagene autoleucel ee loogu talagalay daaweynta bukaanada qaangaarka ah ee qaba lymphoma-ka unugyada B ee soo noqnoqda ama aan firfircoonayn (r/r LBCL) ka dib laba ama in ka badan oo ah daaweyn nidaamsan, waxayna soo saartay shahaadada diiwaangelinta daawada. Relma-cel waa badeecaddii ugu horreysay ee CAR-T oo loo ansixiyey inay tahay badeecad bayooloji ah oo Qaybta 1aad ah oo laga helo Shiinaha, iyo badeecaddii lixaad ee CAR-T ee la ansixiyay adduunka oo dhan.
Ku saabsan Relmacabtagene Autoleucel Injection (magaca ganacsiga: Carteyva®)
Cirbadda Relmacabtagene autoleucel (oo loo soo gaabiyo relma-cel, magaca ganacsiga: Carteyva) waa badeeco iskeed ah oo ka hortagta CD19 CAR-T unugyada difaaca jirka oo ay si madax-bannaan u samaysay JW Therapeutics oo ku salaysan madal habka unugyada CAR-T ee Juno Therapeutics (shirkad Bristol Myers Squibb ah).
Oggolaanshahani wuxuu ku salaysan yahay natiijooyinka daraasad hal-gacan ah, oo xarun badan leh, oo muhiim ah (daraasad RELIANCE) si loo qiimeeyo waxtarka iyo badbaadada relma-cel ee bukaanada qaba r/r LBCL ee Shiinaha. Natiijooyinka daraasadda RELIANCE waxay muujinayaan in relma-cel ay muujisay heer sare oo jawaab celin cudur oo waara iyo heerar hoose oo sunta la xiriirta CAR-T, waxayna bixin kartaa muuqaal daaweyn CAR-T oo heer sare ah.
Shirkii Sanadlaha ahaa ee 24-aad ee Bulshada Kiimikada ee Shiinaha (CSCO), JW Therapeutics waxay ku dhawaaqday natiijo la cusbooneysiiyay oo dabagal ah oo 1 sano ah oo ku saabsan duritaanka relmacabtagene autoleucel (relma-cel) si loogu daaweeyo r/r LBCL. Natiijooyinka waxaa ka mid ah:
Relma-cel waxay muujisay jawaabo waara iyo faa'iido badbaado muddo dheer ah; Heerka Jawaabta Guud ee ugu Fiican (ORR) wuxuu ahaa 77.6%, Heerka Jawaabta Dhameystiran ee ugu Fiican (CRR) wuxuu ahaa 51.7% halka 1-sano ee Badbaadada Guud (OS) uu ahaa 76.8% iyadoo la raacayo celcelis ahaan 17.9 bilood;
Relma-cel guud ahaan si fiican ayaa loogu dulqaatay astaamo badbaado oo ay ku jiraan Cudurka sii deynta Cytokine oo hooseeya (≥fasalka 3) oo ah 5.1% iyo heerka sunta neerfaha oo hooseeya (≥fasalka 3) oo ah 3.4%, mana jiraan calaamado badbaado oo cusub oo leh celcelis ahaan 17.9 bilood oo dabagal ah;
Dabagalka muddada dheer ee daraasadda RELIANCE waxay xaqiijisay waarta jawaabta iyo OS-ga muddada dheer ee daaweynta relma-cell, kaas oo sidoo kale lala xiriiriyay heerarka hooseeya ee sunta la xiriirta CAR-T.
LBCL waa nooca ugu badan uguna gardarrada badan ee lymphoma-ka aan ahayn Hodgkin, bukaanada badankooduna way soo noqdaan ka dib daawaynta bilowga ah iyagoo leh ikhtiyaarro daaweyn oo xaddidan oo leh daaweyn caadi ah iyo badbaado dhexdhexaad ah oo qiyaastii 6 bilood ah. Xogtan dabagalka muddada dheer ee laga soo sheegay daraasadda RELIANCE waxay xaqiijisay cimri dhererka jawaabaha ka dib daaweynta relma-cell, taasoo matalaysa ikhtiyaar daaweyn oo muhiim u ah bukaanadan oo u muuqda inay bixiyaan rajo cad oo ah badbaado dheer.
Waqtigan xaadirka ah, waxaa jira tijaabooyin caafimaad oo badan oo CAR-T ah oo ka jira Shiinaha, waxayna raadinayaan bukaanno. Si aad ula tashato daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
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Tixraacyada
2.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20210903084004127.html
3.https://www.sciencedirect.com/science/article/pii/S0006497118704138
4.https://www.jwtherapeutics.com/en/media/press-release/jw-therapeutics-announces-updated-1-year-follow-up-result-of-relmacabtagene-autoleucel-injection-at-the-24th-annual-conference-of-the-chinese-society-of-clinical-oncology-csco-1/
Waqtiga boostada: Noofambar-15-2024