FDA Approves Combo Treatment for Advanced BRAF-Mutant Melanoma

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 BRAF^V600E or BRAFV^600K 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 BRAF^v600 mutation.

According to the data, encorafenib plus binimetinib doubled the median progression-free survival compared with vemurafenib, alone.

Data announced in February 2018 showed that the combination treatment reduced risk of death compared with vemurafenib 960 mg daily in the planned analysis of overall survival (OS). For patients treated with the combination, median OS was 33.6 months compared with 16.9 months for patients treated with the monotherapy.

Additionally, only 5% of patients who received encorafenib plus binimetinib discontinued treatment due to adverse reactions, according to the press release.

“We are thrilled with the approval of BRAFTOVI + MEKTOVI, which help fill a critical unmet need for patients with advanced BRAF-mutant melanoma, a serious and deadly type of skin cancer,” Ron Squarer, chief executive officer of Array BioPharma, said in a press release. “As presented at ASCO, BRAFTOVI + MEKTOVI is the first targeted treatment to demonstrate over 30 months median survival in a phase 3 trial.”

Encorafenib is not approved for the treatment of patients with wild-type BRAF melanoma.

Reference

Array BioPharma Announces FDA Approval of BRAFTOVI (encorafenib) in Combination with MEKTOVI (binimetinib) [news release]. Array BioPharma’s website. https://www.multivu.com/players/English/8336151-array-biopharma-braftovi-mektovi-fda-approval/. Accessed June 27, 2018.