Professor Thomas Powles, MD from Barts Cancer Centre, London, UK speaks about European Commission Approves BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma.
ROCKLAND, Mass. and NEW YORK, Jan. 25, 2021 /PRNewswire/ — EMD Serono, Merck KGaA, Darmstadt, Germany, US, and Canada Healthcare Business Sector, and Pfizer Inc. (NYSE: PFE) today announced that BAVENCIO® (avelumab) has been approved by the European Commission (EC) as monotherapy for first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinomas.
BAVENCIO plus best supportive treatment (BSC) as first-line maintenance showed a substantial increase in median overall survival (OS) vs BSC alone in the prespecified interim analysis (data cut-off date Oct. 21, 2019) in the pivotal JAVELIN Bladder 100 study: 21.4 months (95% CI: 18.9 to 26.1) vs 14.3 months (95% CI: 12.9 to 17.8) in the coprimary population of all randomized randomized population
BAVENCIO also reported substantially extended OS for all randomized patients vs. BSC alone (HR 0.70; 95 percent CI, 0.56 to 0.86; two-sided P=0.0008), with a median OS of 22.1 months (95 percent CI, 19.0 to 26.1) vs 14.6 months (95 percent CI, 12.8 to 17.8), respectively, with revised OS findings with a data cut-off of Jan. 19, 2020.
BAVENCIO was first approved by the US Food and Drug Administration (FDA) in June 2020 in the US as a first-line maintenance treatment for advanced UC and is now approved for this indication in 38 countries. In 13 countries, including Japan, where approval is required in H1 2021, additional regulatory applications are under review.