EC approves for Merck's Keytruda for bladder cancer indication

The European Commission has approved Merck & Co's Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. Specifically, Keytruda is approved for use as monotherapy for the treatment of 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.

The approval in patients previously treated with platinum-containing chemotherapy was based on superior overall survival for Keytruda versus investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine), as demonstrated in the randomized, phase 3 KEYNOTE-045 trial. The approval in patients ineligible for cisplatin-containing chemotherapy was based on phase 2 data from the KEYNOTE-052 trial, which demonstrated an overall response rate of 29 percent (95% CI, 25-34). The approval allows for the marketing of Keytruda in these two new indications in all 28 EU member states plus Iceland, Lichtenstein and Norway at a dose of 200 mg every three weeks until disease progression or unacceptable toxicity.

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

"Despite advances, there remain limited treatment options available to patients with locally advanced or metastatic urothelial carcinoma who are either not eligible to receive cisplatin-containing chemotherapy – which is platinum-based and currently the standard of care – or for those patients whose cancer returns after receiving prior platinum-containing chemotherapy," said professor Ronald de Wit, group leader experimental systemic therapy of urogenital cancers, Erasmus MC Cancer Institute.