Binimetinib
Mitogen-Activated Protein Kinase (Mek) Inhibitors
Sold as Balimek · MEKTOVI
- Drug class
- Mitogen-Activated Protein Kinase (Mek) Inhibitors
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 6
Overview
Binimetinib is an active pharmaceutical ingredient in the Mitogen-Activated Protein Kinase (Mek) Inhibitors group (L01EE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 4 | May 22, 2026 |
| CA Canada | Health Canada | 1 | April 2, 2026 |
| EU European Union | EMA | 1 | November 5, 2025 |
GBUnited Kingdom· MHRA
4 products
Uses
Melanoma Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Non-small cell lung cancer (NSCLC) Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
How to take
CACanada· Health Canada
1 product
Side effects & warnings
). 1 Pregnancy There are no data from the use of binimetinib in pregnant women. Based on its mechanism of action and animal reproduction studies, MEKTOVI can cause fetal harm when administered to a pregnant woman (see 10 Clinical Pharmacology, Mechanism of Action and 16 Non-Clinical Toxicology).
MEKTOVI should not be used in pregnant women. If the patient becomes pregnant while taking MEKTOVI, the patient should be apprised of potential hazard to the fetus. Advise females of reproductive potential to use effective contraception during treatment with MEKTOVI and for at least 1 month after the final dose.
2 Breastfeeding There are no data on the presence of binimetinib or its active metabolite in human milk, or the effects of binimetinib on the breastfed infant, or on milk production. Because of the potential for serious adverse reactions from MEKTOVI in breastfed infants, advise women not to breastfeed during treatment with MEKTOVI and for 3 days after the final dose.
EUEuropean Union· EMA
1 product
Uses
Melanoma Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Non-small cell lung cancer (NSCLC) Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
How to take
Drug interactions
Known interactions involving Binimetinib. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB006030251 · revised May 22, 2026
- [2]Health Canada (DPD) · 02513080 · revised April 2, 2026
- [3]European Medicines Agency · EMEA/H/C/004579 · revised November 5, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.