FDA New Drug and Biologic Approvals, 2018 Midyear Review

Unresectable or Metastatic Melanoma: Mektovi (binimetinib)

Indication: Indicated in combination with encorafenib for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Mechanism: Inhibits mitogen-activated extracellular signal regulated kinase (MEK) 1 and MEK 2. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK)-related phosphorylation and MEK-dependent phosphorylation of BRAF-mutant human melanoma cell lines.

Dosage: 45 mg PO BID in combination with encorafenib until disease progression or unacceptable toxicity. Dose modifications are recommended for toxicities.

Approval was based on results from the phase 3 COLUMBUS trial, which demonstrated that the combination doubled median progression-free survival (mPFS) compared with vemurafenib alone (14.9 months versus 7.3 months, respectively (P<0.0001).

Reference:

• Dummer R, Ascierto PA, Gogas HJ, et al. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2018 May;19(5):603-615. https://www.ncbi.nlm.nih.gov/pubmed/29573941

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.