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Mektovi 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

Mektovi (binimetinib) is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Development History and FDA Approval Process for Mektovi

DateArticle
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
Sep 28, 2015Clinical Data Presented On Binimetinib And Encorafenib In Melanoma

Further information

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