Merck's Keytruda Wins FDA Approval In Esophageal Cancer Settings

The FDA has approved Merck & Co Inc's MRK Keytruda, anti-PD-1 therapy, to treat esophageal or gastroesophageal junction (GEJ) carcinoma.

• The approval covers patients with locally advanced or metastatic GEJ tumors with an epicenter 1 to 5 centimeters that are not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. 
• The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival, progression-free survival, and the objective response rate for Keytruda plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status.
• This approval was reviewed under the FDA's Real-Time Oncology Review pilot program and the FDA's Project Orbis, an Oncology Center of Excellence initiative.
• Under this project, the FDA, Australian Therapeutic Goods Administration, Health Canada, and Swissmedic collaboratively reviewed the KEYNOTE-590 application.
• The application is still under review in Australia, Canada, and Switzerland.
• Price Action: MRK shares closed at $77.51 on Monday.