Merck Canada announces conditional approval of KEYTRUDA (pembrolizumab) for melanoma treatment

Merck Canada Inc.Jun 8 2015

KEYTRUDA^TM is the First Anti-PD-1 Immuno-Oncology Therapy Available in Canada

Merck Canada Inc. announced today that KEYTRUDA^TM (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."

"The conditional approval of this new product in Canada marks a new era in how advanced melanoma will be treated in this population with a high unmet medical need," said Dr. Marcus Butler, Medical Oncologist at Princess Margaret Cancer Centre, Director of Princess Margaret Immune Monitoring Laboratory. "For patients suffering from symptoms of their advanced disease, the product is not only effective, but also well-tolerated."

"We commend the decision to issue an NOC/c for KEYTRUDA in Canada for metastatic melanoma, the deadliest form of skin cancer," said Kathy Barnard, Founder of the Save Your Skin Foundation. "As a survivor of advanced melanoma myself," she adds, "I know first-hand what great news this is for Canadians suffering from this deadly disease, who might otherwise be out of treatment options. Immuno-oncology is an important development in cancer treatment."

"It is hard to contain my enthusiasm," added Annette Cyr, Chair and Founder, Melanoma Network of Canada. "This new therapy brings us hope to have regression of the disease, improved quality of life and the potential to have a life free of this aggressive cancer."