Merck KGaA and Pfizer Report EMA’s Validation for Bavencio (avelumab) as a 1L Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

 Merck KGaA and Pfizer Report EMA’s Validation for Bavencio (avelumab) as a 1L Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

Merck KGaA and Pfizer Report EMA’s Validation for Bavencio (avelumab) as a 1L Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

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

Click here to read full press release/ article | Ref: Merck KGaA | Image: Specialty Pharma Journal

Related News: Merck KGaA and Pfizer Report Results of Bavencio (avelumab) in P-III JAVELIN Bladder 100 Study for Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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