An amince da amfani da Finotonlimab don maganin cutar kansar ƙwayoyin squamous na kai da wuya

A ranar 8 ga Fabrairu, 2025, Hukumar Kula da Kayayyakin Lafiya ta Ƙasa (NMPA) ta ƙasar Sin ta amince da finotonlimab na Sinocelltech Group Ltd, wani maganin rigakafi na monoclonal monoclonal (mAb) wanda aka tsara don mutuwa 1 (PD-1), don amfani tare da maganin chemotherapy na tushen platinum a matsayin magani na farko don sake dawowa da/ko metastatic na cutar kansar ƙwayoyin squamous na kai da wuya.

Finotonlimab wani nau'in antibody ne mai kama da IgG4 wanda aka sake haɗa shi da ɗan adam wanda ke da cikakken haƙƙin mallakar fasaha. A matsayinsa na sabon magani mai lasisi, tsarin kwayoyin halittarsa ​​na musamman ne kuma yana da fa'idodin tsarin aiki. Finotonlimab yana ɗaure da PD-1 tare da babban ƙarfi, yana toshe hanyar PD-1/PD-L1 yadda ya kamata, yana maido da kuma haɓaka aikin kashe garkuwar jiki na ƙwayoyin T, kuma hakan yana hana ci gaban ƙari.

AGwajin da aka yi bazuwar, mai makanta biyu-biyu, ya kimanta inganci da amincin finotonlimab (SCT-I10A), wani kwayar cuta mai kashe ƙwayoyin cuta ta monoclonal da aka tsara, wanda aka haɗa shi da cisplatin da 5-fluorouracil (C5F) don maganin farko na R/M HNSCC. An ba marasa lafiya da suka cancanta (n = 370) bazuwar 2:1 don karɓar finotonlimab da C5F (n = 247) ko placebo da C5F (n = 123). Babban maƙasudin ƙarshe shine rayuwa gabaɗaya (OS). A cikin ƙungiyar finotonlimab da C5F, OS ya kasance watanni 14.1 (tazara ta amincewa 95% (CI) 11.1–16.4), idan aka kwatanta da watanni 10.5 (95% CI 8.1–11.8) a cikin placebo da ƙungiyar C5F. Rabon haɗarin shine 0.73 (95% CI 0.57–0.95, P = 0.0165), wanda ya cika sharuɗɗan fifiko da aka riga aka ayyana don babban matakin ƙarshe. Finotonlimab da C5F sun nuna babban fifikon OS idan aka kwatanta da C5F kaɗai da kuma bayanin aminci mai karɓuwa tare da R/M HNSCC, suna tallafawa amfani da shi azaman zaɓin magani na farko ga R/M HNSCC. Waɗannan sakamakon sun tabbatar da inganci da amincin haɗin finotonlimab da C5F a cikin marasa lafiyar Asiya da ke fama da R/M HNSCC.

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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Nassoshi

1.国家药品监督管理局 (nmpa.gov.cn)

2.Finotonlimab tare da maganin chemotherapy a cikin ciwon daji na kai da wuya mai sake dawowa ko kuma wanda ya faru: gwajin mataki na 3 na bazuwar | Maganin Yanayi