MEKTOVI

BINIMETINIB

Manufacturer: Array BioPharma Inc.

Score: 141.0

Quick Summary

MEKTOVI (BINIMETINIB) is a kinase inhibitor used in combination with encorafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, and for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. The recommended dose is 45 mg orally twice daily in combination with encorafenib, with dose modifications for adverse reactions and hepatic impairment. MEKTOVI can cause fetal harm and has warnings for cardiomyopathy, venous thromboembolism, and other adverse reactions.

Key Clinical Findings and Indications

MEKTOVI is used in combination with encorafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
MEKTOVI is used in combination with encorafenib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation

Important Safety Information

Warning

MEKTOVI can cause fetal harm when administered to a pregnant woman

Contraindications

Adverse Reactions

Cardiomyopathy
Venous Thromboembolism
Serous Retinopathy
Interstitial Lung Disease
Hepatotoxicity
Rhabdomyolysis
Hemorrhage

Dosing Recommendations

General Guidance

Dose modifications for adverse reactions and hepatic impairment

Melanoma

Adult Dose

45 mg orally twice daily in combination with encorafenib

Pediatric Dose

Not established

NSCLC

Adult Dose

45 mg orally twice daily in combination with encorafenib

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

MEKTOVI can cause fetal harm when administered to a pregnant woman

Nursing Mothers

Pediatric Use

The safety and effectiveness of MEKTOVI have not been established in pediatric patients

Geriatric Use

No overall differences in the safety or effectiveness of MEKTOVI plus encorafenib were observed in older patients as compared to younger patients

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