Maganin Layi na Farko don Ciwon Kankara mara Ƙaramar Kwayoyin Halitta

A KYAUTA Kyauta 6 | eTurboNews | eTN
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Written by Linda Hohnholz

Eli Lilly da Kamfanin a yau sun sanar da cewa Hukumar Kula da Abinci da Magunguna ta Amurka (FDA) ta ba da cikakkiyar wasiƙar amsawa (CRL) don Aikace-aikacen Lasisi na Biologics (BLA) don allurar sintilimab na magani, mai hana PD-1 a hade tare da pemetrexed da platinum chemotherapy don maganin layin farko na mutanen da ke fama da cutar kansar huhu mara kanana (NSCLC). Innovent Biologics, Inc. da Lilly ne ke haɓaka Sintilimab. 

Wasiƙar ta nuna cewa sake zagayowar sake dubawa ya cika amma FDA ba ta iya amincewa da aikace-aikacen a cikin tsari na yanzu, daidai da sakamakon Kwamitin Ba da Shawarar Magunguna na Oncologic a watan Fabrairu. CRL ta haɗa da shawarwarin don ƙarin binciken asibiti, musamman gwaji na asibiti na yanki da yawa wanda ya kwatanta daidaitaccen jiyya don layin farko na metastatic NSCLC zuwa sintilimab tare da chemotherapy ta amfani da ƙira mara ƙarancin ƙarfi tare da ƙarshen rayuwa gaba ɗaya.

Tare da Innovent, Lilly tana tantance matakai na gaba don shirin sintilimab a Amurka

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Avatar na Linda Hohnholz

Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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