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德国制药巨头拜耳近日宣布,美国FDA已授予抗癌药copanlisib新药申请(NDA)优先审查资格,该NDA寻求批准copanlisib作为一种单药疗法,用于既往已接受至少2次治疗的复发性或难治性滤泡性淋巴瘤(FL)患者。优先审查(PR)是FDA的一个新药审查通道,旨在加速开发及审查治疗严重的或危及生命的疾病的新药,保障在最短时间内为患者提供新的治疗选择。根据处方药用户收费法(PDUFA),获得优先审查资格(PRD)的药物,FDA将给予加速审查并在6个月完成审查。(源自:药品资讯网)
German pharmaceutical giant Bayer announced recently that the U.S. FDA has granted preemptive eligibility for the anti-cancer drug copanlisib New Drug Application (NDA) seeking to approve copanlisib as a monotherapy for relapsing or refractory patients who have previously received at least 2 treatments Patients with idiopathic follicular lymphoma (FL). Prioritization (PR) is a FDA new drug review channel designed to accelerate the development and review of new drugs for the treatment of serious or life-threatening conditions and to provide patients with new treatment options in the shortest possible time. Under the PDFA, PRD drugs will be expedited and will be reviewed by the FDA within six months. (From: Drug Information Network)