Bristol-Myers Squibb will be filing its much-touted PD-1 checkpoint inhibitor nivolumab in the near future in the USA as a treatment for melanoma.
The US major says that following discussions with the US Food and Drug Administration, it is planning a third-quarter submission of Opdivo (nivolumab) for previously-treated advanced melanoma. This will be the second tumour type for which B-MS has filed for Opdivo across the pond, having initiated a rolling submission with the FDA in third-line pre-treated squamous cell NSCLC in April; it expects to complete that particular filing by year-end.
The melanoma filing, which will come considerably earlier than expected, is based on data from Checkmate -037, a Phase III trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with B-MS’ own licensed drug Yervoy (ipilimumab) and, if BRAF-mutation positive, a BRAF inhibitor regimen. Last month, the company stopped another Phase III study assessing nivolumab in melanoma after independent regulators found it showed a superior survival benefit over dacarbazine.
In 2013, the FDA granted fast-track designation for Opdivo in NSCLC, melanoma and renal cell carcinoma and in May this year gave the drug breakthrough therapy designation for the treatment of patients with Hodgkin lymphoma. Last week, it was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world after Japan gave the green light to Opdivo, which was filed by B-MS partner Ono Pharmaceutical Co.
Nivolumab will compete with Merck & Co’s PD-1 checkpoint inhibitor pembrolizumab, which has already been filed on both sides of the Atlantic, and has a Prescription Drug User Fee Act date of October 28. A number of other of companies are exploring the PD-1 class, notably Roche and AstraZeneca.
