Hunting a full OK for Bavencio in frontline bladder cancer, Pfizer, Merck KGaA receive VIP treatment at FDA
The JAVELIN Bladder 100 study was one of the rare bright spots in Bavencio’s checkered development record. Now Pfizer and Merck KGaA get to burnish that with a breakthrough therapy designation for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma.
The partners have submitted their sBLA, which is now being reviewed on a real-time basis. Under that pilot program — which began in late 2018 — regulators could access data prior to the official application filing.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.