publication date: Sep. 8, 2017

Drugs and Targets

EC approves Merck’s Keytruda for locally advanced, metastatic urothelial carcinoma

The European Commission approved Merck’s Keytruda (pembrolizumab) for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma.

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) (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 II 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.

“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 for experimental systemic therapy of urogenital cancers, Erasmus MC Cancer Institute. “It is exciting that with this approval of Keytruda, we now also have a new treatment option for patients previously treated with platinum-containing chemotherapy that has shown a clinically meaningful and improved overall survival benefit versus chemotherapy in this difficult-to-treat population.”

The approval in patients previously treated with platinum-containing chemotherapy … Continue reading EC approves Merck’s Keytruda for locally advanced, metastatic urothelial carcinoma

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