Why the FDA Accepted to Review Merck’s KEYTRUDA (sBLA) for The Treatment of HER2 Negative Gastric Adenocarcinoma

Merck in the NEWS

Merck (MRK) announced that the U.S. FDA has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of HER2 negative patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The American Agency's acceptance of . . .

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