Merck KGaA and Pfizer Report EMA’s Validation for Bavencio (avelumab) as a 1L Treatment for Locally Advanced or Metastatic Urothelial Carcinoma
Merck KGaA Collaborated with Burning Rock for Liquid-biopsy Based CDx Development
Shots:
- The EMA has validated the type II variation application for Bavencio which is based on P-III JAVELIN Bladder 100 study assessing Bavencio +BSC vs BSC as monothx. in 700 patients whose disease had not progressed after platinum-based induction CT as per RECIST v1.1
- Following the completion of the application, the EMA will now initiate the review procedure. The study resulted in improving OS which was presented at ASCO20
- Bavencio is a human PD-L1 mAb, acts by blocking the interaction of PD-L1 with PD-1 receptors. In early 2020, the US FDA has accepted the sBLA for 1L treatment of patients with LA or metastatic UC for PR under the FDA’s RTOR pilot program. The FDA has granted BT designation to Bavencio for the same indication
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