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 … Continue reading FDA approves Braftovi + Mektovi combination in a melanoma indication

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