Merck Stock Rises on Positive EU Opinion for Cancer Therapy

Merck & Co., Inc. (NYSE: MRK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin) for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (bladder cancer). This positive opinion brings the combination therapy one step closer to final approval by the European Commission.

Regulatory Details

The CHMP recommended the combination for patients who have not received prior systemic therapy for advanced disease. The recommendation is based on results from the Phase 3 KEYNOTE-A39 trial, which showed statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared to standard chemotherapy.

Company's Position

Merck welcomed the positive opinion, reiterating its commitment to expanding treatment options for patients. The company stated it looks forward to the European Commission's final decision.

Precedents and Context

KEYTRUDA has previously received multiple EU approvals across various cancer types, while Padcev was previously approved as a monotherapy for bladder cancer after chemotherapy failure. If approved, this would be the first combination therapy for this indication in Europe.

Potential Financial Impact

The potential approval could boost Merck's revenue from KEYTRUDA, one of the world's top-selling drugs, and expand the market for Padcev, which is co-developed with Astellas Pharma. Merck has not provided specific financial guidance.