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

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

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BlauJournal