Thaum Lub Tsib Hlis 22, 2025, Allist Pharmaceuticals tau tshaj tawm tias nws cov tshuaj tshiab Airuikai (Glecirasib Citrate Tablets), uas yog ib yam tshuaj uas tiv thaiv KRAS-G12C, tau txais kev pom zoo los ntawm National Medical Products Administration (NMPA). Kev pom zoo no tso cai rau Airuikai siv rau kev kho mob rau cov neeg laus uas muaj KRAS®®G12C-mutated advanced non-small cell lung cancer (NSCLC) uas tau txais tsawg kawg ib kab kev kho mob thoob plaws lub cev. Qhov no yog lwm txoj kev kho mob qog nqaij hlav tshiab uas Allist Pharmaceuticals tau pom zoo, muab kev xaiv kho mob tshiab rau cov neeg mob uas muaj KRASG12C-mutated non-small cell lung cancer (NSCLC) thiab pab kho dua tshiab rau hom kab mob qog nqaij hlav no uas nyuaj kho.
Kev pom zoo yog raws li cov txiaj ntsig los ntawm kev tshawb fawb theem II ib leeg uas ntsuas kev nyab xeeb, kev kam rau siab, thiab kev ua tau zoo ntawm Glecirasib monotherapy rau cov neeg mob uas muaj mob qog nqaij hlav tsis yog me me uas muaj KRASG12Cmutations uas tsis ua tiav lossis tsis kam rau cov kev kho mob ib txwm muaj.
Cov txiaj ntsig tau qhia tias Goleresai muaj txiaj ntsig zoo thiab tiv taus tau zoo. Txij li thaum lub Cuaj Hlis 28, 2024, tag nrho muaj 119 tus neeg mob NSCLC tau suav nrog hauv kev tshuaj xyuas. Tus nqi teb tau lees paub (cORR), raws li tau soj ntsuam los ntawm Pawg Neeg Saib Xyuas Kev Ywj Pheej (IRC), yog 49.6% (40.2% -59.0%), nrog rau tus nqi tswj kab mob (DCR) ntawm 86.3% (78.7% -92.0%). Lub sijhawm nruab nrab ntawm kev teb (DOR) yog 14.5 lub hlis (9.6 lub hlis tsis kwv yees tau), lub neej nruab nrab tsis muaj kev nce qib (PFS) yog 8.2 lub hlis (5.2–11.1), thiab lub neej nruab nrab tag nrho (OS) yog 17.5 lub hlis (13.6 lub hlis tsis kwv yees tau).
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Tsib Hlis-27-2025