Merck Gets Positive CHMP Opinion For Keytruda Plus Padcev To Treat Urothelial Carcinoma

(RTTNews) - Merck & Co., Inc. (MRK) announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion recommending the approval of Keytruda in combination with Padcev for treating metastatic urothelial carcinoma.

This recommendation is based on positive overall survival and progression-free survival observed in the Phase 3 KEYNOTE-A39 trial, conducted in partnership with Pfizer and Astellas.

If approved, this combination would mark Keytruda's third indication for bladder cancer in the European Union.

Keytruda, which is Merck's anti-PD-1 therapy, is proposed for use with Padcev, an antibody-drug conjugate, as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.

The company expects a final decision on the marketing authorization for Keytruda in combination with Padcev in the third quarter of 2024.