Prescription medicine
Binimetinib Brand names: Mektovi
Binimetinib (Mektovi) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the binimetinib FDA label on DailyMed (effective March 20, 2025, Array BioPharma Inc.); the NDA 210498 record on Drugs@FDA; every binimetinib label on DailyMed.
Highlights of the record
FDA label of March 20, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMEKTOVI 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.
Forms and strengths
- 15 mg
Film-coated tablet.
On the market
- Earliest approval on file
- June 27, 2018 Mektovi, Array Biopharma Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 18, 2033 Mektovi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest March 8, 2023
- FAERS reports
- 7,756 through July 30, 2026
What is binimetinib used for?
From the label: indications and usageMEKTOVI 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. […]
Conditions named in the indications of binimetinib's FDA labels, with every medicine labeled for each:
Source: FDA drug label (MEKTOVI), Array BioPharma Inc., effective March 20, 2025 (SPL set 6c3408ac-d401-4925-8a03-26591afbc240), via openFDA; the full label on DailyMed
What does the patient leaflet for binimetinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about MEKTOVI when taken in combination with encorafenib?MEKTOVI when taken in combination with encorafenib may cause serious side effects, including: • Risk of new skin cancers. MEKTOVI, when used with encorafenib, may cause skin cancers called cutaneous squamous cell carcinoma or basal cell carcinoma. Talk to your healthcare provider about your risk for these cancers. Check your skin and tell your healthcare provider right away about any skin changes, including a: o new wart o skin sore or reddish bump that bleeds or does not heal o change in size or color of a mole Your healthcare provider should check your skin before treatment with MEKTOVI, when taken in combination with encorafenib, every 2 months during treatment, and for up to 6 months after you stop treatment to look for any new skin cancers. Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment with MEKTOVI when taken in combination with encorafenib. See " What are the possible side effects of MEKTOVI? " for more information about side effects.
From the patient leaflet: How should I store MEKTOVI?Store MEKTOVI at room temperature between 68°F to 77°F (20°C to 25°C). Keep MEKTOVI and all medicines out of the reach of children.
Source: FDA drug label (MEKTOVI), Array BioPharma Inc., effective March 20, 2025 (SPL set 6c3408ac-d401-4925-8a03-26591afbc240), via openFDA; the full label on DailyMed
Is there a generic for binimetinib (Mektovi)?
No generic binimetinib is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 7 patents for Mektovi tablets: the compound patent runs to October 18, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has binimetinib been recalled?
The FDA's Enforcement Report lists 1 recall naming binimetinib since 2023: 0 Class I (the most serious), 0 Class II, 1 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 8, 2023 | Class III | Pfizer Inc. | Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the binimetinib label say about other medicines?
The binimetinib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name binimetinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Encorafenib | warnings and precautions | New Primary Malignancies, Cutaneous and Non-cutaneous: Can occur when MEKTOVI is used in combination with encorafenib. |
Source: FDA drug label (MEKTOVI), Array BioPharma Inc., effective March 20, 2025 (SPL set 6c3408ac-d401-4925-8a03-26591afbc240), via openFDA; the full label on DailyMed
What do FAERS reports show for binimetinib?
The FDA Adverse Event Reporting System holds 7,756 reports that list binimetinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,209 are coded as a death and 2,258 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as binimetinib?
26 other medicines are given the same way (oral) and in the same FDA class as binimetinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Dacomitinib | Lung cancer | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as binimetinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to binimetinib
- 26 medicines for the same use
- Binimetinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other