FDA approves Merck’s Keytruda for gastric cancer treatment
Merck, known as MSD outside of the US, has announced that the US Food and Drug Administration (FDA) has approved Keytruda in combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The approval follows data from the phase 3 KEYNOTE-859 trial, in which Keytruda in combination with chemotherapy reduced the risk of death by 22% compared to chemotherapy alone. Median overall survival (OS) was 12.9 months for Keytruda compared to 11.5 months with chemotherapy alone.
Immune-mediated adverse reactions could include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejections and complications of allogeneic hematopoietic stem cell transplantation.
Dr Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories, commented: “At Merck, we have a comprehensive development program across a broad range of gastrointestinal cancers with the goal of providing meaningful new options to patients and their healthcare providers. This latest approval of a KEYTRUDA-based treatment option is an important milestone for patients with advanced HER2-negative gastric or GEJ adenocarcinoma and reinforces Merck’s commitment to addressing the needs of these patients in the US.”
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