Avelumab Gains Accelerated Approval for Urothelial Carcinoma

The approval comes within months of avelumab being approved for the treatment of Merkel cell carcinoma.

Patients with locally advanced or metastatic urothelial carcinoma who are refractory to platinum-based chemotherapy can now be treated with a new immunotherapy treatment. Avelumab received an approval for Merkel cell carcinoma in November of last year.

The approval for bladder cancer comes following an open-label, single-arm, multicenter trial that included 242 patients whose disease had progressed on or after platinum-based chemotherapy or within 12 months of a platinum-containing neoadjuvant or adjuvant chemotherapy. The overall response rate following a 10 mg/kg intravenous dose of avelumab was 13.3% (95% CI, 9.1-18.4) in 30 patients who had been followed for at least 13 weeks, and 16.1% (95% CI, 10.8-22.8) in 26 patients who had been followed for at least 6 months. The median response to duration ranged from 1.4 to 17.4 months in both groups, but had not yet been reached at the time of analysis.

The most common adverse reactions that occurred in at least 20% of patients were fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection.

The drug is being developed by EMD Serono.