Array Withdraws Binimetinib's US Filing On Heels Of Late-Cycle Meeting With FDA

Company explored ‘a number of paths to approval’ with agency, but modest progression-free survival benefit in monotherapy treatment of NRAS-mutant melanoma appears to have doomed the new drug application, which was pulled less than two weeks before advisory committee review.

The late-cycle meeting required by the US FDA user fee review program cemented Array BioPharma Inc.’s decision to withdraw its new drug application (NDA) for the oncologic binimetinib (MEK162) ahead of an advisory committee review.

On March 17, Array withdrew the NDA for binimetinib, a MEK inhibitor, for monotherapy treatment of NRAS-mutant melanoma. The withdrawal...

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