European Commission (EC) Approves Merck & Co.’s KEYTRUDA (Pembrolizumab) For The Treatment Of Certain Patients With Locally Advanced Or Metastatic Urothelial Carcinoma, A Type Of Bladder Cancer

Published: Sep 05, 2017

Now Approved for Adults Previously Treated with Platinum-Containing Chemotherapy and for Adults Ineligible for Cisplatin-Containing Chemotherapy

Only Anti-PD-1 Therapy to Demonstrate Superior Overall Survival Versus Chemotherapy in Patients with Advanced Urothelial Carcinoma Post-Platinum Failure

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved 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 (OS) for KEYTRUDA versus investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) (HR, 0.73 [95% CI: 0.59, 0.91], p=0.002), 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 (ORR) 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.

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