Merck Sharp and Dohme’s Keytruda approved for urothelial carcinoma in Europe

Merck Sharp and Dohme has announced that its anti-PD-1 therapy Keytruda has been approved in Europe for the treatment of an advanced form of bladder cancer.

The European Commission has approved Keytruda as a monotherapy for locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, as well as adults who are not eligible for cisplatin-containing chemotherapy.

This decision came after the drug was able to demonstrate superior overall survival rates compared to chemotherapy in these patient groups in the phase III KEYNOTE-045 and KEYNOTE-052 trials.

Currently, the number of treatment options available for patients with advanced urothelial carcinoma are limited, especially for those who fail to respond to chemotherapy.

Dr Roger Dansey, senior vice-president and therapeutic area head for oncology late-stage development at Merck Research Laboratories, said: "Our focus is now on working with health authorities in Europe to ensure access for these patients as quickly as possible."

Keytruda has now been evaluated in more than 550 trials, making this the largest immuno-oncology programme in the industry.

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