Merck: FDA Approves KEYTRUDA With Chemotherapy For First-Line Treatment Of Esophageal, GEJ Carcinoma

(RTTNews) - Merck (MRK) said FDA has approved KEYTRUDA, the company's anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. The approval was reviewed under the FDA's Real-Time Oncology Review pilot program and the FDA's Project Orbis.

The company said the FDA approval is based on results from the phase 3 KEYNOTE-590 trial, which showed significant improvements in overall survival, progression-free survival and objective response rate for KEYTRUDA plus fluorouracil and cisplatin versus fluorouracil and cisplatin alone, regardless of histology or PD-L1 expression status.