Mektovi

Treats unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. NDA 210498, held by Array Biopharma Inc. Binimetinib.

As of Nov 14, 2026, NDA 210498 (Mektovi), held by Array Biopharma Inc, was first approved by FDA on Jun 27, 2018, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 27, 2018
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MEKTOVI 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. ( 1.1, 2.1 )
in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. ( 1.2, 2.1 ) 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first


Mar 12, 2025	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Sep 12, 2024	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 11, 2023	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 23, 2019	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 27, 2018	Original applicationNew molecular entity · Standard review	Approved	Label Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mektovi15MG · tablet;oral	Binimetinib	RxReference drug

Identifiers

Application: NDA 210498
Drugs@FDA: Overview at FDA
Company: Array BioPharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters