The U.S. Food and Drug Administration (FDA) approves Bavencio®as first-line maintenance treatment for certain patients with locally advanced or metastatic urothelial carcinoma

Chemotherapy has been the first-line standard of care for patients living with locally advanced or metastatic urothelial carcinoma for more than 40 years.¹ However, most patients will ultimately experience disease progression within nine months of initiation of treatment, and only 5% of patients with metastatic disease at diagnosis will live longer than five years.^2,3 

Bavencio was approved in June by the U.S. FDA under its Real-Time Oncology Review pilot program for the first-line maintenance treatment of patients living with advanced urothelial carcinoma. Also in December, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of Bavencio for the same indication. Along with plans to share the data with regulatory agencies around the world, the Pfizer-Merck KGaA, Darmstadt, Germany alliance set the path for a new option for many living with this disease today.

“We believe there is real potential for first-line maintenance immunotherapy to change the practice of how we treat locally advanced or metastatic urothelial carcinoma,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “Given the critical unmet need to address the high level of disease progression and low survival rate, the JAVELIN Bladder 100 data reinforce the potential of first-line maintenance therapy using Bavencio to extend overall survival in patients without disease progression with induction chemotherapy.”