Combo Therapy for Advanced BRAF-Mutant Melanoma Gets FDA Approval

Article

The FDA has granted approval to Array BioPharma’s encorafenib (Braftovi) capsules in combination with binimetinib (Mektovi) tablets for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E or BRAFV600K mutation.

Officials with the FDA have approved Array BioPharma’s encorafenib (Braftovi) capsules in combination with binimetinib (Mektovi) tablets for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E or BRAFV600K mutation, according to a press release.

Approximately half of the 200,000 cases of melanoma diagnosed each year have BRAF mutations, according to Array BioPharma. Despite recent advances in treatment, there remains an unmet need for therapies that are effective and well-tolerated for patients with BRAF-mutant melanoma.

Encorafenib is an oral small molecule BRAF kinase inhibitor and binimetinib is an oral small molecule MEK inhibitor that target key enzymes in the MAPK signaling pathway.

The approval is based on results from the phase 3 COLUMBUS trial evaluating the efficacy and safety of the combination therapy compared with vemurafenib and encorafenib monotherapy. The trial included 921 patients with locally advanced, unresectable, or metastatic melanoma with BRAFv600 mutation.

Click to continue reading on Specialty Pharmacy Times.

Related Videos
A panel of 3 experts on multiple myeloma
A panel of 3 experts on multiple myeloma
Video 12 - "Collaborative Care: Key Stakeholders in HE Treatment and Recovery"
Video 11 - "Optimizing Transitions of Care for Hepatic Encephalopathy Patients"
Video 10 - "Valuable Metrics and Improving Adherence in Patients With ASCVD"
Video 9 - "The Role of Pharmacists in Treating Very High-Risk ASCVD"
Video 6 - "evaluating CDK4/6 inhibitor safety profiles"
Video 5 - "CDK4/6 Inhibitor Sequencing and NCCN Guidelines in mBC"
Video 8 - "Challenges of Concurrent Administration: RSV and Other Vaccines "
Video 7 - "Raising RSV Awareness Among High-Risk Patient Populations "
© 2024 MJH Life Sciences

All rights reserved.