Merck & Co Inc (NYSE:MRK) announced on Thursday that its anti-PD-1 therapy Keytruda in combination with chemotherapy has been approved by the U.S. Food and Drug Administration (FDA) for gastric cancer.
This marks the 38th indication to win approval for Keytruda regimens in the United States and the seventh gastrointestinal cancer indication, Merck highlighted.
The company said the approval is based on its Phase 3 Keynote-859 trial in which Keytruda plus fluoropyrimidine- and platinum-containing chemotherapy reduced the risk of death by 22% compared to treatment with chemotherapy on its own.
The median overall survival rate was 12.9 months for the Keytruda combination compared to 11.5 months for chemotherapy alone.
“This latest approval of a KEYTRUDA-based treatment option is an important milestone for patients with advanced HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma and reinforces Merck’s commitment to addressing the needs of these patients in the U.S.,” Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories said in a statement.
Merck shares traded modestly lower in early trade on Friday, down 0.2% at US$101.77.
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