Posted by Michael Wonder on 09 Apr 2020
Merck and Pfizer receive US FDA breakthrough therapy designation and submit application for Bavencio for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
9 April 2020 - Breakthrough therapy designation and submission based on positive Phase III JAVELIN Bladder 100 study results.
Merck and Pfizer today announced completion of the submission of a supplemental Biologics License Application to the US FDA for Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma.
The FDA granted breakthrough therapy designation to Bavencio for this indication, and the application is being reviewed by the FDA under its real-time oncology review pilot program.
