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# Array Bio Pulls NDA Filling Over Clinical Benefit Concerns
- URL: https://www.fdaweb.com/array-bio-pulls-nda-filling-over-clinical-benefit-concerns/
- Published: 2017-03-20T12:00:00.000Z
- Updated: 2026-09-14T22:12:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138240

Array BioPharma has withdrawn its recent NDA for binimetinib monotherapy for treating NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer. The company says the withdrawal was based on a discussion with FDA 3/17 that concluded the clinical benefit demonstrated in the Phase 3 NEMO clinical trial would not be found sufficient to support approval. Ongoing clinical trials for binimetinib will continue, Array says. The *NRAS* gene provides instructions for making a protein called N-Ras that is involved primarily in regulating cell division.