AZ's Imfinzi gets accelerated approval in bladder cancer

FDA granted accelerated approval to Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat locally advanced or metastatic urothelial carcinoma in the second-line setting, regardless of PD-L1 status. Specifically, the PD-L1-targeted mAb is indicated for patients with disease progression during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

AZ spokesperson Michele Meixell told BioCentury the company plans to launch Imfinzi this week at an average monthly wholesale acquisition cost (WAC) of about $15,000, although prices will vary based on health insurance status and individual prescriptions...