Health Canada approves Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab)

Opdivo is the first anti PD-1 (programmed death-1) approved to treat previously untreated cases of BRAF V600 wild-type unresectable or metastatic melanoma in adults. The approval was made under the Health Canada Priority Review process, after having met the criteria of substantial evidence of clinical effectiveness providing an improved benefit/risk profile over existing therapies.

The CheckMate-066 phase 3 study was stopped early when an independent data review showed evidence of superior overall survival in patients receiving Opdivo over chemotherapy treatment dacarbazine (DTIC). The one-year survival rate was 73 per cent for those on Opdivo compared to 42% for DTIC. Those on Opdivo had a 58% decrease in the risk of death based on a hazard ratio of 0.42 (99.79% CI, 0.25-0.73; p

"The pioneering science that led to the introduction of the first immunotherapy to treat a very deadly form of cancer dramatically changed not only the way advanced melanoma is managed but also the outcome. Today, we now have the option to offer newly diagnosed patients an anti PD-1 therapy. This seems like the natural next step in a disease area that has transformed significantly to the benefit of our patients," said Dr. Michael Smylie , an oncologist specializing in melanoma at the Cross Cancer Institute in Edmonton .

"Extending survival is a reality and the study results we’ve seen with Opdivo are very encouraging. This approval is yet another very important step forward."

Metastatic melanoma should not be underestimated. It is the deadliest form of skin cancer and represents 8% of all cases of skin cancer in Canada but accounts for 70% of deaths from the disease. Immunotherapy advances are positively impacting outcomes for patients.

"We are now seeing progress and the benefit of tremendous research in the treatment of metastatic melanoma. It is an amazing turning point for those of us who had previously despaired about treatment options and offering real hope to patients," said Annette Cyr , Chair and Founder of the Melanoma Network of Canada.

"The rapid advances in immuno-oncology, as shown by this newest treatment approval, are very encouraging and we hope public payers will move quickly to complete their evaluations and make Opdivo available to all Canadian patients."

"In just a short period metastatic melanoma went from being defined as a deadly disease to a disease with people who are surviving. This approval is more than just another new treatment, it’s someone’s opportunity to live a longer life," said Kathy Barnard , Founder of the Save Your Skin Foundation and herself a survivor of metastatic melanoma.

"The results of the ongoing research are giving patients treatment options and that’s remarkable. I’m here today witnessing history being made. In fact, I’m living proof of it."