FDA Approves Merck's Blockbuster Cancer Drug For Type Of Gastric Cancer

The FDA has approved Merck & Co Inc's MRK Keytruda, an anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The approval is based on data from the Phase 3 KEYNOTE-859 trial, in which Keytruda plus chemotherapy reduced the risk of death by 22% compared to chemotherapy alone for these patients. 

Median overall survival (OS) was 12.9 months for Keytruda plus chemotherapy versus 11.5 months for chemotherapy alone.

The approval marks the seventh gastrointestinal cancer indication for Keytruda-based regimens and the 38th indication for Keytruda in the U.S.

Earlier this month, the FDA approved Keytruda, in combination with gemcitabine and cisplatin, for locally advanced unresectable or metastatic biliary tract cancer, marking the sixth indication for Keytruda in gastrointestinal cancers.

The FDA's Pulmonary-Allergy Drugs Advisory Committee will convene Friday to discuss Merck's marketing application seeking approval for chronic cough oral drug gefapixant. The U.S. health regulator raised the concerns after Merck had submitted additional efficacy data.

Price Action: MRK shares are up 0.72% at $102.72 during the premarket session on the last check Friday.