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news.US-based Bristol-Myers Squibb (BMS) is planning a third quarter submission of a Biologics Licensing Application (BLA) to the US Food and Drug Administration (FDA) for Opdivo (nivolumab) for previously treated advanced melanoma.
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The move follows BMS’ discussions with FDA and will mark the second tumor type for which the company has a regulatory submission underway for Opdivo in the US.
Bristol-Myers Squibb head of Oncology Development Michael Giordano said, "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."
The BLA is based on data a multinational, multicenter, randomized open-label Phase III trial called from Checkmate -037, evaluating nivolumab 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.
The company has proposed the name Opdivo, which, if approved by health authorities, will serve as the trade name for nivolumab.
A broad, global development program is being carried out by the company to evaluate Opdivo in multiple tumor types consisting of over 35 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled across the world.
Image: BMS proposed the name Opdivo to be served as the trade name for nivolumab. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net