FDA accelerated approval for Imfinzi for bladder cancer

The US Food and Drug Administration has granted accelerated approval to Imfinzi (durvalumab), the agency’s latest approval for a PD-L1 checkpoint inhibitor.

Developed by AstraZeneca (LSE: AZN) and its biotech research arm MedImmune, Imfinzi is indicated for the treatment of patients with locally-advanced or metastatic urothelial carcinoma (mUC), or bladder cancer, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. The drug is approved under the FDA’s accelerated approval pathway, based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Imfinzi will compete in the bladder cancer sector with the likes of Roche’s Tecentriq (atezolizumab), which gained approval for this indication last year, and Bristol-Myers’ Opdivo (nivolumab), which was approved for bladder cancer in February.