Pa June 26, 2025, CARsgen yalengeza kuti National Medical Products Administration (NMPA) ya ku China yavomereza New Drug Application (NDA) ya satricabtagene autoleucel (“satri-cel”, CT041) (mankhwala a autologous CAR T-cell omwe amalimbana ndi puloteni Claudin18.2) pochiza Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) mwa odwala omwe alephera njira ziwiri zoyambirira za chithandizo. Kuperekedwa kwa NDA makamaka kumadalira zotsatira za mayeso azachipatala otseguka, ambiri, komanso olamulidwa mwachisawawa a Phase II (CT041-ST-01, NCT04581473) omwe anachitika ku China. Detayi yaperekedwa mu The Lancet ndi pa Msonkhano Wapachaka wa 2025 wa American Society of Clinical Oncology (ASCO).
About Satri-cel
Satri-cel ndi mankhwala a CAR T-cell omwe amapangidwa ndi autologous motsutsana ndi puloteni ya Claudin18.2 yomwe ikhoza kukhala yoyamba padziko lonse lapansi. Satri-cel imayang'ana kwambiri kuchiza zotupa zolimba za Claudin18.2, makamaka G/GEJA ndi khansa ya kapamba (PC). Mayeso oyambilira akuphatikizapo mayeso oyambitsidwa ndi ofufuza (CT041-CG4006, NCT03874897), mayeso otsimikizira a Gawo Lachiwiri la G/GEJA yapamwamba ku China (CT041-ST-01, NCT04581473), mayeso olembetsa a Phase Ib a PC adjuvant therapy ku China (CT041-ST-05, NCT05911217), mayeso oyambitsidwa ndi ofufuza a satri-cel omwe amagwiritsidwa ntchito ngati chithandizo cholimbitsa pambuyo pa chithandizo chowonjezera mwa odwala omwe ali ndi G/GEJA yochotsedwa (CT041-CG4010, NCT06857786), ndi mayeso achipatala a Gawo 1b/2 a adenocarcinoma yapamwamba ya m'mimba kapena pancreatic ku North America (CT041-ST-02, NCT04404595).
Satri-cel yapatsidwa Priority Review ndi Center for Drug Evaluation (CDE) ya NMPA yaku China yochizira Claudin18.2-positive advanced G/GEJA mwa odwala omwe adalephera njira ziwiri zochiritsira mu Meyi 2025. Satri-cel yapatsidwa Breakthrough Therapy Designation ndi CDE ya NMPA yaku China yochizira Claudin18.2-positive advanced G/GEJA mwa odwala omwe adalephera njira ziwiri zochiritsira mu Marichi 2025. Satri-cel yapatsidwa Regenerative Medicine Advanced Therapy ndi US FDA yochizira G/GEJA yapamwamba yokhala ndi zotupa za Claudin18.2 mu Januwale 2022. Satri-cel idalandira Orphan Drug kuchokera ku US FDA yochizira G/GEJA mu Seputembala 2020.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Qi, Changsong ndi ena. Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) motsutsana ndi chithandizo cha dokotala chomwe adasankha pa khansa ya m'mimba kapena gastro-oesophageal junction yomwe idachiritsidwa kale (CT041-ST-01): mayeso otseguka, osankhidwa mwachisawawa, a gawo lachiwiri. The Lancet, Voliyumu 0, Nkhani 0
Nthawi yotumizira: Juni-26-2025