publication date: Jun. 29, 2018

Drugs & Targets

FDA approves Braftovi + Mektovi combination in a melanoma indication

FDA has approved Braftovi capsules in combination with Mektovi tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.

Braftovi is not indicated for the treatment of patients with wild-type BRAFmelanoma.

The treatment is sponsored by Array BioPharma Inc.

The approval of Braftovi + Mektovi is based on results from the  III COLUMBUS trial, which demonstrated the combination doubled median progression-free survival, compared to Zelboraf (vemurafenib), alone (14.9 months versus 7.3 months, respectively [HR (0.54), (95% CI 0.41-0.71), p<0.0001]). Only 5 percent of patients who received Braftovi + Mektovi discontinued treatment due to adverse reactions.

The most common adverse reactions (≥25%) in patients receiving Braftovi + Mektovi were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia.

In February, the company announced that Braftovi + Mektovi reduced the risk of death compared to treatment with vemurafenib 960 mg daily [hazard ratio (HR) of 0.61, [95% CI 0.47, 0.79, p <0.001] in the planned analysis of overall survival (OS) from the COLUMBUS trial.

Median OS was 33.6 months for patients treated with the combination, compared to 16.9 months for patients treated with vemurafenib as a monotherapy. These positive results add to the growing body of clinical evidence supporting the BRAF/MEK inhibitor combination therapy and Array and its partners are working to formally submit these results with global regulatory authorities.

Braftovi is an oral small molecule BRAF kinase inhibitor and Mektovi is an oral small molecule MEK inhibitor which target key enzymes in the MAPK … Continue reading FDA approves Braftovi + Mektovi combination in a melanoma indication

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