Bristol-Myers Squibb Company today announced that, following discussions with the U.S. Food and Drug Administration (FDA), the company is planning a third quarter submission of a Biologics Licensing Application (BLA) for Opdivo® (nivolumab) for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S.
“We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb.
The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine (DTIC) or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy® (ipilimumab) and, if BRAF-mutation positive, a BRAF inhibitor regimen.
Bristol-Myers Squibb has proposed the name Opdivo (pronounced op-dee-voh) , which, if approved by health authorities, will serve as the trade name for nivolumab.