艾伯维提交了BLA申请,要求加速批准telisotuzumab vedotin用于治疗具有c- Met过度表达的晚期NSCLC. AbbVie files BLA for accelerated approval of telisotuzumab vedotin for advanced NSCLC with c-Met overexpression.
艾伯维向FDA提交了一份生物药品许可申请,要求对先前治疗过的,已发达的非小细胞肺癌 (NSCLC) 患者的telisotuzumab vedotin (Teliso- V) 获得加速批准. AbbVie has filed a Biologics License Application with the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V) for adults with previously treated, advanced non-small cell lung cancer (NSCLC) exhibiting c-Met overexpression. 在第二阶段LUMINOSITY试验数据的支持下,Teliso-V旨在为这种得不到充分服务的病人提供新的治疗选择,因为目前没有经批准的治疗其病情的疗法。 Supported by Phase 2 LUMINOSITY trial data, Teliso-V aims to provide a new treatment option for this underserved patient population, as there are currently no approved therapies for their condition.