Pa Seputembala 6, 2021, JW Therapeutics yalengeza kuti National Medical Products Administration (NMPA) ya ku China yavomereza New Drug Application (NDA) ya anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection (relma-cel) yochizira odwala akuluakulu omwe ali ndi relaxation kapena refractory large B-cell lymphoma (r/r LBCL) pambuyo pa njira ziwiri kapena zingapo zochizira, ndipo yatulutsa satifiketi yolembetsa mankhwala. Relma-cel ndi mankhwala oyamba a CAR-T ovomerezeka ngati mankhwala a Gulu 1 ku China, komanso mankhwala achisanu ndi chimodzi ovomerezeka a CAR-T padziko lonse lapansi.
Zokhudza Relmacabtagene Autoleucel Injection (dzina la malonda: Carteyva®)
Relmacabtagene autoleucel injection (yofupikitsidwa ngati relma-cel, dzina lamalonda: Carteyva) ndi mankhwala oletsa chitetezo cha mthupi a maselo a CD19 CAR-T omwe adapangidwa paokha ndi JW Therapeutics kutengera nsanja ya maselo a CAR-T ya Juno Therapeutics (kampani ya Bristol Myers Squibb).
Kuvomerezedwa kumeneku kumachokera ku zotsatira za kafukufuku wa mkono umodzi, wa malo ambiri, wofunikira (kafukufuku wa RELIANCE) kuti awone momwe relma-cel imagwirira ntchito komanso chitetezo chake mwa odwala omwe ali ndi r/r LBCL ku China. Zotsatira za kafukufuku wa RELIANCE zikuwonetsa kuti relma-cel inawonetsa kuchuluka kwa kuyankha kwa matenda okhazikika komanso kuchuluka kochepa kwa poizoni wokhudzana ndi CAR-T, ndipo ikhoza kupereka chithandizo chabwino kwambiri cha CAR-T.
Pa Msonkhano Wapachaka wa 24 wa Chinese Society of Clinical Oncology (CSCO), JW Therapeutics yalengeza zotsatira zatsopano za chaka chimodzi zotsatiridwa ndi jakisoni wa relmacabtagene autoleucel (relma-cel) pochiza r/r LBCL. Zotsatira zake zikuphatikizapo:
Relma-cel inasonyeza mayankho okhazikika komanso phindu la nthawi yayitali lopulumuka; Chiŵerengero Chabwino Kwambiri Choyankha (ORR) chinali 77.6%, Chiŵerengero Chabwino Kwambiri Choyankha (CRR) chinali 51.7% ndipo Chiŵerengero Chonse Chopulumuka (OS) cha chaka chimodzi chinali 76.8% ndi zotsatira zapakati pa miyezi 17.9;
Relma-cel nthawi zambiri inali yovomerezeka bwino ndi mbiri ya chitetezo kuphatikizapo Cytokine Release Syndrome yotsika kwambiri (≥giredi 3) ya 5.1% ndi mlingo wochepa kwambiri wa poizoni wa mitsempha (≥giredi 3) wa 3.4%, ndipo palibe zizindikiro zatsopano zachitetezo zokhala ndi apakatikati a miyezi 17.9 yotsatiridwa;
Kutsatira kwa nthawi yayitali kafukufuku wa RELIANCE kwatsimikizira kulimba kwa yankho ndi OS ya nthawi yayitali pogwiritsa ntchito relma-cell, zomwe zidagwirizananso ndi kuchuluka kochepa kwa poizoni wogwirizana ndi CAR-T.
LBCL ndi mtundu wofala kwambiri komanso woopsa wa non-Hodgkin lymphoma ndipo odwala ambiri amabwereranso pambuyo polandira chithandizo choyamba ndi njira zochepa zochiritsira ndi njira zochiritsira zokhazikika komanso kupulumuka kwapakati kwa miyezi pafupifupi 6. Deta yotsatirayi yomwe yaperekedwa kuchokera ku kafukufuku wa RELIANCE yatsimikizira kulimba kwa mayankho pambuyo pa chithandizo cha relma-cel, chomwe chikuyimira njira yofunika kwambiri yothandizira odwalawa yomwe ikuwoneka kuti ikupereka chiyembekezo chotsimikizika cha kupulumuka kwa nthawi yayitali.
Pakadali pano, pali mayeso ena ambiri azachipatala a CAR-T ku China, ndipo akufunafuna odwala. Kuti mumve zambiri za mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Zolemba
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-meeting-of-the-chinese-society-of-clinical-oncology-csco-1/
Nthawi yotumizira: Novembala-15-2024