Musi wa26 Chikumi, 2025, CARsgen yakazivisa kuti National Medical Products Administration (NMPA) yeChina yakagamuchira New Drug Application (NDA) ye satricabtagene autoleucel ("satri-cel", CT041) (chigadzirwa cheCAR T-cell chinorwisa protein Claudin18.2) chekurapa Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) muvarwere vakakundikana kurapwa kaviri. Kuendeswa kweNDA kunonyanya kubva pamhedzisiro yeongororo yekiriniki yePase II (CT041-ST-01, NCT04581473) yakaitwa muChina. Ruzivo urwu rwakaunzwa muThe Lancet uye paMusangano wegore negore we2025 American Society of Clinical Oncology (ASCO).
Nezve Satri-cel
Satri-cel chigadzirwa cheCAR T-cell chinogadzirwa nemuviri chinopesana neprotein inonzi Claudin18.2 iyo inogona kuva yekutanga mukirasi pasi rose. Satri-cel inotarisa kurapa Claudin18.2-positive solid bundu ichinyanya kutarisa paG/GEJA nekenza yepancreatic (PC). Miedzo yakatanga inosanganisira miedzo yakatangwa nevaongorori (CT041-CG4006, NCT03874897), bvunzo yekiriniki yePhase II yekusimbisa G/GEJA yepamusoro muChina (CT041-ST-01, NCT04581473), bvunzo yekunyoresa yePhase Ib yekurapa kwePC adjuvant muChina (CT041-ST-05, NCT05911217), bvunzo yakatangwa nevaongorori ye satri-cel inoshandiswa sekurapa kwekubatanidza mushure mekurapa kwe adjuvant muvarwere vane G/GEJA yakabviswa (CT041-CG4010, NCT06857786), uye bvunzo yekiriniki yePhase 1b/2 yekurapa kwe advanced gastric or pancreatic adenocarcinoma muNorth America (CT041-ST-02, NCT04404595).
Satri-cel yakapihwa Priority Review neCenter for Drug Evaluation (CDE) yeNMPA yeChina yekurapa Claudin18.2-positive advanced G/GEJA kuvarwere vakakundikana kurapwa kaviri muna Chivabvu 2025. Satri-cel yakapihwa Breakthrough Therapy Designation neCDE yeNMPA yeChina yekurapa Claudin18.2-positive advanced G/GEJA kuvarwere vakakundikana kurapwa kaviri muna Kurume 2025. Satri-cel yakapihwa Regenerative Medicine Advanced Therapy naUS FDA yekurapa G/GEJA yepamusoro ine Claudin18.2-positive tumors muna Ndira 2022. Satri-cel yakapihwa Orphan Drug kubva kuUS FDA yekurapa G/GEJA muna Gunyana 2020.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
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Qi, Changsong nevamwe. Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) zvichienzaniswa nekurapwa kwesarudzo yachiremba kune kenza yemudumbu kana gastro-oesophageal junction yakamborapwa (CT041-ST-01): bvunzo yechikamu chechipiri isina kurongeka. The Lancet, Vhoriyamu 0, Nyaya 0
Nguva yekutumira: Chikumi-26-2025