This decision is based on the promising results from the Phase III clinical trial, CheckMate-037, which assessed the efficacy of nivolumab plus dacarbazine or carboplatin/paclitaxel in previously ipilimumab (Yervoy) or BRAF inhibitor treated patients with unresectable or metastatic melanoma.
Opdivo, a Bristol-Myers Squibb experimental therapy, had already received a breakthrough therapy designation as a treatment for patients with previously treated melanoma and patients with Hodgkin lymphoma. Furthermore, along with the FDA, the European Medicines Agency (EMA) also granted an accelerated assessment to the medication.
“The filing acceptance and validation of our Opdivo applications by the FDA and EMA represent significant steps forward in our commitment to delivering innovative immuno-oncology treatments to patients with cancer around the world. Additionally, the breakthrough therapy designation and the accelerated assessment for advanced melanoma underscore our focus on developing treatments for diseases in which a significant unmet medical need remains,” Michael Giordano, MD, senior vice president, Head of Oncology Development, Bristol-Myers Squibb, said in a company’s press release.
Nivolumab had already proven to extend overall survival when compared to dacarbazine in 418 untreated patients with advanced melanoma in the phase III CheckMate-066 trial.
“The outcome of CheckMate-066 is an important milestone in the field of immuno-oncology as it represents the first well-controlled, randomized phase III trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit. Bristol-Myers Squibb is committed to continuing to lead advances in immuno-oncology and to executing our strategy to provide patients with the best opportunity to achieve the potential for long term survival,” Giordano said in one of the company’s press releases.
Further results from another ongoing Phase I clinical study were presented at the 2014 ASCO Annual Meeting, where a 41% 3-year overall survival rate in advanced melanoma patients treated with single-agent nivolumab was demonstrated.
Earlier this year, nivolumab was granted approval in Japan as a treatment for patients with unresectable melanoma. Moreover, this PD-1 inhibitor is currently being investigated for the treatment of non-small cell lung cancer (NSCLC) and renal cell carcinoma.