EMD Serono and Pfizer’s Bavencio (avelumab) Receive the US FDA’s Breakthrough Therapy Designation as 1L Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

Shots:

• The companies have completed the submission of sBLA to the US FDA as 1L maintenance therapy for patients with LA/m-UC and have received FDA’s BT designation for the same indication. The sBLA is being reviewed under the FDA’s RTOR pilot program
• The sBLA is based on P-III JAVELIN Bladder 100 study assessing Bavencio + BSC vs BSC as monothx. in 700 patients with UC with no disease progression after platinum-based induction CT
• The study resulted in meeting 1EPs of OS in each of the co-primary populations of all randomized patients and patients with PD-L1-positive tumors. Bavencio is a PD-L1 antibody, acts by blocking the interaction of PD-L1 with PD-1 receptors

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