Bristol-Myers Squibb reports that the US Food and Drug Administration (FDA) has accepted for filing and review the company’s supplemental biologics license application (sBLA) for Opdivo (nivolumab) for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted priority review for this application. The projected FDA action date is August 27, 2015.

Opdivo was first approved by the FDA in December 2014 for patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This initial indication was approved under accelerated approval based on tumor response rate and durability of response from CheckMate -037 clinical trial results. This new sBLA accepted by the FDA includes data from CheckMate -066, which evaluated Opdivo in treatment naïve patients with BRAF wild-type advanced melanoma as compared to dacarbazine chemotherapy (DTIC). In the trial, safety and tolerability were well-characterized with fewer treatment-related Grade 3/4 adverse events observed with Opdivo than dacarbazine.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the FDA as a monotherapy in two cancer indications. In the US, Opdivo is also indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. On March 5, 2015, Opdivo received FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.

Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide.

Source: Bristol-Myers Squibb