Merck: FDA Grants Priority Review To SBLA For Keytruda Plus Chemotherapy

Merck & Co. Inc. (MRK) said Thursday that the U.S. Food and Drug Administration has granted priority review for a new supplemental Biologics License Application or sBLA for KEYTRUDA in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction (GEJ).

This sBLA is based on data from the pivotal Phase 3 KEYNOTE-590 trial. In the trial, KEYTRUDA plus chemotherapy demonstrated significant improvements in the primary endpoints of overall survival (OS) and progression-free survival (PFS), versus chemotherapy in these patients regardless of PD-L1 expression status and tumor histology. KEYTRUDA is Merck’s anti-PD-1 therapy.

Merck said it presented the data at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

The FDA has set a Prescription Drug User Fee Act date (PDUFA date) as April 13, 2021.

KEYTRUDA is currently approved in the U.S., China and Japan as monotherapy for the second-line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus.

Merck is continuing to study KEYTRUDA across multiple settings and stages of gastrointestinal cancer – including gastric, hepatobiliary, esophageal, pancreatic, colorectal and anal cancers – through its clinical program.

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