Array BioPharma recently announced that it has sent the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for its binimetinib treatment for patients who have advanced NRAS-mutant melanoma.
The NDA is founded on results from the Phase 3 NEMO (NRAS MELANOMA AND MEK INHIBITOR) study. This study showed that binimetinib has notably lengthened the median progress-free survival (PFS) for the patients over the results from decarbazine.
"The new drug application for binimetinib represents Array's first — an important milestone for this promising compound and our company," Ron Squarer, CEO of Array BioPharma, said. "NRAS-mutant melanoma represents an often overlooked subset of advanced disease without meaningful treatment options beyond immunotherapy and NEMO is the first-ever trial to meet a PFS endpoint in this population. We look forward to working with the FDA as they evaluate our application and the potential for binimetinib as a treatment option for these patients."
The extension reached 2.8 months, which is a significant improvement over the 1.5 months found with decarbazine.
“While the results in the pre-specified sub-group of patients who had received prior treatment with immunotherapy are of interest, interpretation beyond overall consistency with the primary result should be made with care,” Squarer said. “Array anticipates that the primary consideration for marketing approval will be the results for the primary endpoint of the trial."