KENILWORTH (NJ) (dpa-AFX) - Merck & Co Inc. (MRK) on Friday said its Keytruda in combination with fluoropyrimidine- and platinum-containing-chemotherapy has been approved by Health Canada for the treatment of gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults.
This approval is based on results from the Phase 3 KEYNOTE-859 trial, in which treatment with Keytruda plus chemotherapy showed statistically significant improvement in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to placebo in combination with chemotherapy in patients with gastric cancers.
Keytruda was first approved in 2014 by the US FDA to treat advanced or unresectable melanoma. It is currently approved for several indications including advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, cervical cancer, among others.
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