FDA Accepts for Review 2 Array NDAs for Melanoma Therapy

FDA has accepted for review two Array BioPharma NDAs to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for treating patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The company says that FDA told it that based on a preliminary review there are no issues requiring an advisory committee meeting. The agency set a review target action date of 6/30/2018.

The submissions are based on findings from the pivotal Phase 3 COLUMBUS trial, which showed that COMBO450 significantly extend progression-free survival (PFS) in patients with advanced BRAF-mutant melanoma, with a PFS of 14.9 months compared with 7.3 months observed with vemurafenib. “As part of the trial design, the primary analysis was based on a Blinded Independent Central Review (BICR) of patient scans, while results by local review at the investigative site were also analyzed,” the company says.