FX.co ★ Merck Says Health Canada Oks KEYTRUDA In Combination With Trastuzumab And Chemotherapy

Merck and Co., Inc. (MRK), globally recognized as MSD, announced on Monday that Health Canada has given its approval for the use of KEYTRUDA (pembrolizumab), which is Merck's anti-PD-1 therapy. The therapy will be used in combination with trastuzumab, as well as fluoropyrimidine and platinum-based chemotherapy. This approved treatment is designed for initial treatment of adult patients suffering from locally advanced non-removable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma. The effectiveness for this type of treatment will apply to the tumors that express PD-L1, as validated by a specific test.

The approval from Health Canada is realized on the conclusion of the Phase 3 KEYNOTE-811 trial. The trial highlighted a statistically significant advancement in progression-free survival (PFS) in comparison to a placebo combined with trastuzumab and chemotherapy in the context of the intention-to-treat study population.