Bristol-Myers Squibb Announces Plans for Third Quarter Submission of a Biologics License Application for Opdivo

Bristol-Myers Squibb Company (BMS) has announced that, following discussions with 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 tumour type for which BMS has a regulatory submission underway for Opdivo in the US.

“We continue to collaborate closely with 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, BMS.

The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase III 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.

BMS has proposed the name Opdivo (pronounced op-dee-voh), which, if approved by health authorities, will serve as the trade name for nivolumab.