Array BioPharma has submitted a New Drug Application (NDA) for the U.S. Food and Drug Administration (FDA) for binimetinib in the treatment of patients with advanced NRAS-mutant melanoma, according to a release.1
The submission is based on results from the phase 3 NRAS Melanoma and MEK Inhibitor (NEMO) study, which showed that binimetinib was able to extend median progression-free survival by 2.8 months, in contrast with 1.5 months with dacarbazine.
Among a pre-specified subset of patients who had received prior treatment with immunotherapy, including ipilimumab, nivolumab or pembrolizumab, the researchers found that patients who received binimetinib had 5.5 months of median progression-free survival, in contrast with 1.6 months among those who received treatment with dacarbazine.
“While the results in the pre-specified subgroup 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,” Ron Squarer, Chief Executive Officer of Array, said in the release.
Overall response rate was 15% with binimetinib in contrast with 7% for dacarbazine, and disease control rate was 58% with binimetinib and 25% with dacarbazine. While no statistically significant difference was found for overall survival, researchers did find that median overall survival favored the group treated with binimetinib at 11 months, in contrast to 10.1 months with dacarbazine.
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“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,” Squarer said.
- Array BioPharma Submits Binimetinib New Drug Application to U.S. FDA [news release]. Array BioPharma. Boulder, CO. June 30, 2016. http://www.prnewswire.com/news-releases/array-biopharma-submits-binimetinib-new-drug-application-to-us-fda-300292795.html. Accessed July 1, 2016.