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Avelumab sBLA Filed for Frontline Maintenance in Urothelial Carcinoma, Breakthrough Designation Granted

Jason M. Broderick @jasoncology
Published: Thursday, Apr 09, 2020

Petros Grivas, MD

Petros Grivas, MD, PhD
A supplemental Biologics License Application (sBLA) has been filed with the FDA for avelumab (Bavencio) for the frontline maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma, according to EMD Serono (Merck KGaA) and Pfizer, the codevelopers of the PD-L1 inhibitor.1 

“For the past 30 years, chemotherapy has been the first-line standard of care for patients with advanced urothelial carcinoma. While this is an effective short-term option for many patients, most will ultimately experience disease progression, underscoring a need for additional treatment options,” Petros Grivas, MD, PhD, one of the principal investigators in the JAVELIN Bladder 100 trial, said in a press release. “Based on the positive overall survival results from JAVELIN Bladder 100, I believe avelumab has the potential to be practice-changing.”
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