Health Canada approves Opdivo for treating metastatic melanoma

Bristol-Myers Squibb announced that Health Canada has approved Opdivo for metastatic melanoma.

The approval by the Health Canada Priority Review process makes Opdivo (nivolumab) the first anti–PD-1 treatment approved for adults with previously untreated cases of BRAF V600 wild-type unresectable or metastatic melanoma, according to a press release. The approval was based on meeting criteria of substantial evidence of clinical effectiveness providing an improved benefit/risk profile over existing therapies.

An independent data review of the CheckMate-066 phase 3 study showed nivolumab to be superior to dacarbazine chemotherapy for overall survival in 418 patients with BRAF V600 wild-type metastatic melnoma, resulting in the study being stopped early, according to the release. It is the first phase 3 trial of a PD-1 immune checkpoint inhibitor to demonstrate superior overall survival in advanced melanoma, according to the release.

Patients treated with nivolumab had a 1-year survival rate of 73% compared with a 42% rate for patients treated with dacarbazine. Patients treated with nivolumab experienced a 58% decrease in risk of death based on hazard ratio of 0.42 (99.79% CI, 0.25-0.73), the release reported.

“Today, we now have the option to offer newly diagnosed patients an anti–PD-1 therapy,” Michael Smylie, MD, FRCPC, an oncologist specializing in melanoma at Cross Cancer Institute in Edmonton, Alberta, Canada, said in the release. “This seems like the natural next step in a disease area that has transformed significantly to the benefit of our patients. Extending survival is a reality and the study results we’ve seen with Opdivo are very encouraging.”

Nivolumab’s recommended dose is 3 mg/kg IV over 60 minutes every 2 weeks. Continuation of treatment should be as long as clinical benefit is observed or until no longer tolerated by the patient, according to the release.

Reference: www.bmscanada.ca