Merck KgaA : EU Approves Bavencio To Treat Locally Advanced Or Metastatic Urothelial Carcinoma

EMD Serono, the Healthcare business sector of Merck KgaA (MKGAY.PK), and Pfizer Inc. (PFE) said that the European Commission has approved Bavencio or avelumab as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma or UC who are progression-free following platinum-based chemotherapy.

Bavencio maintenance treatment significantly extended median overall survival versus standard of care in the Phase III JAVELIN Bladder 100 study.

Bavencio was first approved in the US as a first-line maintenance treatment for advanced urothelial carcinoma by the US Food and Drug Administration in June 2020 and is now approved for this indication in 38 countries. Additional regulatory applications are under review in 13 countries, including in Japan, where approval is expected in the first-half 2021.

Bavencio in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma.

Bavencio is currently approved for patients in 50 countries for at least one use.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Bea Lydecker's Naturals, Inc. is recalling six Living Free brand dietary supplement products citing undeclared soy lecithin, the U.S. Food and Drug Administration said. According to the agency, the labels declare lecithin but do not declare soy lecithin. Investment banking major Morgan Stanley plans to block employees and clients who are not fully vaccinated against COVID-19 from entering its New York offices, the Financial Times reported citing an internal memo. The policy is expected to come into effect on July 12, and all unvaccinated employees will lose building access from then onwards. Oklahoma City, Oklahoma -based Prairie Wolf Spirits, Inc. is recalling certain Prairie Wolf Distillery hand sanitizer packaged in containers that resemble water bottles, the U.S. Food and Drug Administration said. The product poses a risk of ingestion. The recall involves all lots of Prairie Wolf Distillery hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers.
Follow RTT