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Mektovi FDA Approval History

FDA Approved: Yes (First approved June 27, 2018)
Brand name: Mektovi
Generic name: binimetinib
Dosage form: Tablets
Company: Array BioPharma Inc.
Treatment for: Melanoma, Metastatic, Non Small Cell Lung Cancer

Mektovi (binimetinib) is a kinase inhibitor used for the treatment of melanoma and non-small cell lung cancer.

Development timeline for Mektovi

DateArticle
Oct 11, 2023Approval FDA Approves Braftovi (encorafenib) with Mektovi (binimetinib) for Metastatic Non-Small Cell Lung Cancer with a BRAF V600E Mutation
Jun 27, 2018Approval FDA Approves Mektovi (binimetinib) and Braftovi (encorafenib) in Combination for Unresectable or Metastatic Melanoma with BRAF Mutations
Mar 19, 2017Array BioPharma Announces Withdrawal of NDA for Binimetinib Monotherapy for the Treatment of NRAS-Mutant Melanoma
Sep  1, 2016Array BioPharma Announces FDA Acceptance of Binimetinib NDA for Patients with Advanced NRAS-Mutant Melanoma
Jun 30, 2016Array BioPharma Submits Binimetinib New Drug Application to U.S. FDA

Further information

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