Health Canada Approves Keytruda-Padcev Combo For Certain Patients With Urothelial Cancer

(RTTNews) - Thursday, Merck & Co., Inc. (MRK) announced that Health Canada has approved its blockbuster cancer drug Keytruda for yet another indication.

Keytruda in combination with antibody-drug conjugate Padcev (enfortumab vedotin) has been approved for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) with no prior systemic therapy for mUC.

The approval was based on results from the phase III KEYNOTE-A39 trial, in which the combination of KEYTRUDA and enfortumab vedotin demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared to platinum-based chemotherapy.

Keytruda received its first approval in Canada in 2015. The drug is approved for a number of indications including advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma, colorectal cancer, endometrial carcinoma, cervical cancer, esophageal cancer, triple-negative breast cancer, melanoma, and head and neck squamous cell carcinoma.

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