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Array BioPharma’s Post-Approval Business Strategy Stymied

 
• By John Davis

Following a meeting with the US FDA, Array BioPharma has withdrawn the NDA for its MEK inhibitor binimetinib because of insufficient evidence of clinical benefit in a tough-to-treat subgroup of melanoma patients, that may lead to a rethink of its commercialization strategy.

Melanoma

The US biotech Array BioPharma Inc. says its withdrawal of the US NDA for the MEK inhibitor binimetinib for the treatment of NRAS-mutant melanoma will not affect the filing of the combination, binimetinib plus the BRAF inhibitor encorafenib, in the larger indication, BRAF-mutant melanoma, but the stock market was still disappointed with the withdrawal, with the company’s share price knocked down by 34% in pre-market trading on March 20.

The decision will likely disrupt Array BioPharma’s overall business strategy based on using the approval and introduction of lead product binimetinib in a small indication as a launch pad for...

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