Breakthrough status for Bavencio in first-line metastatic urothelial carcinoma

9 April 2020

Germany’s Merck KGaA (MRK: DE) and US pharma giant Pfizer (NYSE: PFE) today announced completion of the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC).

The FDA granted Breakthrough Therapy designation to Bavencio for this indication, and the sBLA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program.

The companies are jointly developing and commercializing Bavencio through a strategic alliance signed in November 2014.

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