Ku ya 26 Kamena 2025, CARsgen yatangaje ko Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA) mu Bushinwa cyemeye Porogaramu Nshya y’Imiti (NDA) kuri satricabtagene autoleucel ("satri-cel", CT041) (umuti wa CAR T-cell candidate urwanya poroteyine Claudin18.2) wo kuvura Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) ku barwayi bananiwe nibura imirongo ibiri yabanje yo kuvura. Itangwa rya NDA rishingiye ahanini ku byavuye mu igerageza ry’icyiciro cya kabiri cy’ubuvuzi (CT041-ST-01, NCT04581473) ryakorewe mu Bushinwa. Amakuru yatanzwe muri The Lancet no mu nama ngarukamwaka ya 2025 American Society of Clinical Oncology (ASCO).
Ibyerekeye Satri-cel
Satri-cel ni ubwoko bwa CAR T-cells bukomoka ku bwoko bwa autologous ugereranyije na poroteyine Claudin18.2 ishobora kuba iya mbere ku isi. Satri-cel igamije kuvura ibibyimba bikomeye bya Claudin18.2 hibandwa cyane kuri G/GEJA na kanseri ya pancreas (PC). Igerageza ryatangijwe ririmo igerageza ryatangijwe n’abashakashatsi (CT041-CG4006, NCT03874897), igerageza ry’icyiciro cya kabiri cy’ubuvuzi rigamije kuvura G/GEJA iteye imbere mu Bushinwa (CT041-ST-01, NCT04581473), igerageza ryo kwiyandikisha rya Phase Ib ku buvuzi bw’inyongera bwa PC mu Bushinwa (CT041-ST-05, NCT05911217), igerageza ryatangijwe n’abashakashatsi ku birebana na satri-cel rikoreshwa nk’ubuvuzi bwo guhuza nyuma yo kuvura abarwayi bafite G/GEJA yakuwemo (CT041-CG4010, NCT06857786), n’igerageza ryo kuvura rya Phase 1b/2 ku ndwara ya kanseri y’igifu cyangwa pancreas iteye imbere muri Amerika y’Amajyaruguru (CT041-ST-02, NCT04404595).
Satri-cel yahawe isuzuma ry’ibanze n’Ikigo gishinzwe gusuzuma imiti (CDE) cya NMPA yo mu Bushinwa mu kuvura Claudin18.2-positive advanced G/GEJA ku barwayi bananiwe nibura imirongo ibiri yabanje yo kuvura muri Gicurasi 2025. Satri-cel yahawe isuzuma ry’ibanze ry’ubuvuzi na CDE wa NMPA yo mu Bushinwa mu kuvura Claudin18.2-positive advanced G/GEJA ku barwayi bananiwe nibura imirongo ibiri yabanje yo kuvura muri Werurwe 2025. Satri-cel yahawe isuzuma ry’ubuvuzi bugezweho bwo kuvura na US FDA mu kuvura G/GEJA iteye imbere ifite ibibyimba bya Claudin18.2 muri Mutarama 2022. Satri-cel yahawe isuzuma ry’imiti y’impfubyi na US FDA mu kuvura G/GEJA muri Nzeri 2020.
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
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Qi, Changsong n'abandi. Claudin-18 isoform 2-specific CAR T-treatment (satri-cel) ugereranije n'ubuvuzi bw'abaganga bahisemo kanseri y'igifu cyangwa gastro-oesophageal junction (CT041-ST-01): igerageza ryakozwe mu buryo butunguranye, rifunguye, icyiciro cya 2. Lancet, Umubumbe wa 0, Issue 0
Igihe cyo kohereza: Kamena-26-2025