Bristol-Myers to file Opdivo BLA earlier than expected

Following discussions with the US Food and Drug Administration, Bristol-Myers Squibb (NYSE: BMY) 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 B-MS has a regulatory submission underway in the USA for Opdivo, a PD-1 Immune checkpoint inhibitor, which has recently received FDA Breakthrough designation for the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant and brentuximab.

The planned filing comes sooner than expected. Mark Schoenebaum, an analyst with ISI Group, said many analysts had not expected Bristol-Myers to submit the marketing application until mid-2015, although he and some others had speculated an earlier filing was possible.