25 September 2015 - Bristol-Myers Squibb continues to lead with advances in immuno-oncology with the latest approval by Health Canada of Opdivo (nivolumab) for metastatic melanoma. 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<0.0001).

"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."

For more details, go to: http://www.newswire.ca/news-releases/bristol-myers-squibbs-immunotherapy-opdivo-nivolumab-approved-by-health-canada-for-the-treatment-of-previously-untreated-braf-v600-wild-type-metastatic-melanoma-529581751.html