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Array BioPharma in disarray over withdrawal of NDA

pharmafile | March 20, 2017 | News story | Manufacturing and Production, Sales and Marketing Array Biopharma 

Array BioPharma has announced that it has pulled its new drug application (NDA) for its drug, binimetinib, for the treatment of NRAS-mutant melanoma. The drug was found to display only marginal efficacy over standard treatment.

According to Array, the decision was reached in communication with the FDA that had suggested the evidence provided would not be strong enough to achieve approval. Array stated that: “Ongoing clinical trials for binimetinib will continue. This action will not impact the planned Phase 3 COLUMBUS trial NDA of binimetinib, in combination with encorafenib, for the treatment of BRAF-mutant melanoma, which remains on track for mid-2017.”

The treatment is for a particularly rare form of metastatic melanoma; it is only found in approximately 2,000 people annually in the US.

In this instance, the drug had been applied as a monotherapy. Previously, data presented on the drug had shown that a Phase 2 study had demonstrated a 15% confirmed response rate and a median duration of response of 11.1 months. As mentioned, Array will persist with the drug as part of a combination therapy in another type of melanoma.

Array BioPharma’s share fell by 14.7% on the news of the failure of its NDA.

Ben Hargreaves

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