Braftovi

Treats unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. NDA 210496, held by Array Biopharma Inc. Encorafenib.

As of Nov 13, 2026, NDA 210496 (Braftovi), held by Array Biopharma Inc, was first approved by FDA on Jun 27, 2018, with 11 approved supplements and 0 published complete response letters.

First approved: Jun 27, 2018
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

BRAFTOVI is a kinase inhibitor indicated: Melanoma

in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1, 2.1 ) Colorectal Cancer (CRC)
in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA‑authorized test. ( 1.2, 2.1 )
in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-authorized test, after prior therapy. ( 1.2, 2.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Feb 24, 2026	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 24, 2026	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Mar 12, 2025	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 20, 2024	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Sep 12, 2024	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 11, 2023	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 8, 2020	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 24, 2019	Supplement 3Efficacy (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	Review Letter Label

Products

2 strengths and forms

Product	Active ingredient	Marketing
Braftovi50MG · capsule;oral	Encorafenib	DiscontinuedReference drug
Braftovi75MG · capsule;oral	Encorafenib	RxReference drug

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 24, 2026	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 24, 2026	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Mar 12, 2025	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 20, 2024	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Sep 12, 2024	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 13, 2023	Supplement 15Labeling · Standard review	Approved	Label Letter
Oct 11, 2023	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 11, 2022	Supplement 13Labeling · Standard review	Approved	Letter Label
Apr 8, 2020	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 24, 2019	Supplement 3Efficacy (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	Review Letter Label

Identifiers

Application: NDA 210496
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