NMPA Ta Amince da Trastuzumab Rezetecan (SHR-A1811) don HER2-Mutated NSCLC

A ranar 29 ga Mayu, Hukumar Kayayyakin Lafiya ta Kasa (NMPA) ta amince da maganin conjugate na HER2 da aka yi niyya ga maganin rigakafi (ADC) trastuzumab rezetecan (SHR-A1811) don tallatawa. An nuna shi a matsayin maganin da aka yi amfani da shi don magance manyan marasa lafiya da ke fama da cutar kansar huhu ta hanyar da ba a iya cirewa ba ko kuma wanda ba shi da ƙananan ƙwayoyin cuta (NSCLC) waɗanda ke da sauye-sauyen HER2 (ERBB2) kuma sun sami aƙalla magani ɗaya a baya. Wannan shine ADC na farko da aka haɓaka a China wanda aka amince da shi ga marasa lafiya da ke da NSCLC mai canzawa ta HER2, yana ba da sabon zaɓi na magani ga wannan yawan marasa lafiya.

An amince da wannan amincewa ne bisa ga muhimmin binciken HORIZON-Lung, wanda Farfesa Lu Shun daga Asibitin Chest na Shanghai ya jagoranta.

Binciken HORIZON-Lung gwaji ne na asibiti mai cibiyoyi da yawa, wanda aka buɗe, wanda ƙungiyar Farfesa Lu Shun ke jagoranta a Asibitin Chest na Shanghai. Sashen Mataki na I yana da nufin tantance matsakaicin adadin da aka yarda da shi (MTD) na trastuzumab rezetecan da kuma tantance ingancinsa na farko da amincinsa ga marasa lafiya da ke ɗauke da NSCLC mai canzawa ta HER2. Tsarin binciken ya haɗa da matakan ƙaruwa da faɗaɗa allurai. A ɓangaren Mataki na I, trastuzumab rezetecan ya nuna aikin farko na hana ƙari da kuma kyakkyawan yanayin aminci. An tsara binciken Mataki na II don ƙara tantance inganci da amincin trastuzumab rezetecan a cikin marasa lafiya da ke ɗauke da NSCLC mai canzawa ta HER2.

Jimillar marasa lafiya 94 ne aka yi wa rajista a ƙarshe a cikin binciken. Sakamakon ya nuna cewa ƙimar amsawar da aka yi da gangan (ORR), kamar yadda Kwamitin Bita Mai Zaman Kansa (IRC) ya kimanta, ya kasance 74.5%, tare da ƙimar kula da cututtuka (DCR) na 98.9%. Matsakaicin tsawon lokacin amsawar (DoR) ya kasance watanni 9.8. Binciken ƙananan ƙungiyoyi ya nuna cewa ingancin trastuzumab rezetecan ya kasance daidai a cikin ƙananan ƙungiyoyi daban-daban na marasa lafiya, ba tare da la'akari da maganin hana tyrosine kinase (TKI) da aka yi a baya ba ko kuma kasancewar ƙwayoyin cuta na asali a cikin kwakwalwa.

Rayuwa ba tare da ci gaba ba (PFS) da IRC ta tantance ta nuna matsakaicin PFS na watanni 11.5, tare da ƙimar PFS na watanni 12 na 48.6%. PFS da mai bincike ya tantance (INV) ya kasance watanni 12.5, tare da ƙimar PFS na watanni 12 na 51.4%.

Jimillar bayanan rayuwa (OS) ba su cika ba tukuna, tare da matsakaicin tsarin aiki ba a kai ga cimma shi ba kuma ƙimar tsarin aiki na watanni 12 na 88.2%.

A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.

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