Merck: new approval for Keytruda in Canada
The American biopharmaceutical group reports that Health Canada has authorized the antibody to be marketed in combination with trastuzumab and chemotherapy for the treatment of patients with gastric or esophago-gastric junction adenocarcinoma.
The Canadian authority's green light covers the non-operable, locally advanced or metastatic HER2-positive form of the disease, whose tumors express the PD-L1 gene.
Approval is based on the results of a Phase III study demonstrating a statistically significant improvement in progression-free survival.
In a press release, Merck points out that patients with advanced gastric adenocarcinoma or esophago-gastric junction disease, which is difficult to treat, have until now had limited treatment options.
First approved in Canada in 2015, Keytruda is currently indicated for a number of diseases, including bladder cancer, classical Hodgkin's lymphoma and cervical cancer.
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