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FDA Approves Expanded Indication for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Adult Patients With Locally Advanced or Metastatic Urothelial Cancer

Published: 2023-12-15 22:00:00 ET

Approval is based on results from the Phase 3 KEYNOTE-A39 trial, which demonstrated a superior overall survival benefit with KEYTRUDA plus Padcev versus platinum-based chemotherapy (gemcitabine plus cisplatin or carboplatin) in these patients

Approval expands the use of KEYTRUDA plus Padcev for locally advanced or metastatic urothelial cancer regardless of cisplatin eligibility

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. The FDA approved this application nearly five months ahead of the PDUFA goal date of May 9, 2024.

The approval is based on data from the Phase 3 KEYNOTE-A39 trial (also known as EV-302) in 886 patients with locally advanced or metastatic urothelial cancer, which was conducted in a research collaboration with Pfizer (previously Seagen) and Astellas. In the trial, KEYTRUDA plus enfortumab vedotin demonstrated a statistically significant improvement in the trial’s major efficacy endpoints of overall survival (OS) and progression-free survival (PFS) versus platinum-based chemotherapy (gemcitabine plus cisplatin or carboplatin). KEYTRUDA plus enfortumab vedotin reduced the risk of death by 53% (HR=0.47 [95% CI, 0.38-0.58]; p

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.