Merck’s Keytruda (pembrolizumab) receives conditional approval in Canada for the treatment of advanced melanoma

Canada (Oncology)

Merck Canada Inc. announced today that Keytruda (pembrolizumab) was authorized for sale with conditions by Health Canada on May 19, 2015. Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to fight advanced melanoma, the most serious form of skin cancer. It is the first of a new class of therapies called anti-PD-1s approved in Canada. Among the different types of skin cancer, melanoma has the greatest metastatic potential.

Keytruda is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor. The product has been approved in Canada under the Notice of Compliance with Conditions (NOC/c) policy on the basis of promising evidence of clinical effectiveness and pending the results of trials to verify its anticipated benefit.

“All of us at Merck Canada are thrilled with Keytruda being available in Canada for the treatment of advanced melanoma, as it provides new therapy to patients facing this difficult- to-treat cancer,” said Chirfi Guindo, Managing Director, Merck Canada Inc. “This new product embodies Merck’s unwavering commitment to be at the forefront of scientific discovery and innovation to help Canadian patients.”

For more details, go to: http://www.merck.ca/Assets/News/Merck_Canada_KEYTRUDA_MELANOMA_EN.pdf

Michael Wonder

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Michael Wonder

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