+ Regulatory
Russell Boniface | Sep 13, 2017

Merck's Keytruda wins European approval as bladder cancer treatment

Merck recently announced that the European Commission has approved Keytruda as an antibody treatment for advanced bladder cancer in the European Union (EU).

Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumor cells in the urinary bladder, called metastatic urothelial carcinoma, Merck said in a release.

The approval is for adult patients who have received platinum-based chemotherapy and patients who are ineligible for cisplatin-based chemotherapy.

"This approval of Keytruda is important for patients with advanced urothelial carcinoma,” Dr. Roger Dansey, senior vice president and therapeutic area head of oncology late-stage development at Merck Research Laboratories, said in a recent release. “Our focus is now on working with health authorities in Europe to ensure access for these patients as quickly as possible.”

The approval allows Merck to market Keytruda in all 28 EU member states.

Urothelial carcinoma is the most common type of bladder cancer and starts in the urothelial cells that line the inside of the bladder.

According to Merck, approximately 430,000 people worldwide in 2012 were diagnosed with bladder cancer and 165,000 died from the disease. 

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