FDA Gives Approval to the Drug Combination Therapy for Melanoma


The United States FDA (Food & Drug Administration) has given approval to dabrafenib (Tafinlar) & trametinib (Mekinist) in combination for the treatment of patients having melanoma with BRAF V600K & V600E mutations. This drug combination is regarded as the breakthrough for the treatment of melanoma as per the latest medical research.

In addition to the given combination of drugs, the FDA has also given approval to the drug bioMerieux as the companion diagnostic drug for the given therapeutics. The combination of the drugs has been observed to slow down the progression of melanoma in the patients. Moreover, this combination also aids in improving the OS (Overall Survival) rate of the patients having melanoma. The approval given by FDA to the combination of the drugs has been made on the basis of the results that were obtained from the COLUMBUS Trial. This trial was a randomized, open-label, active-controlled, multicenter trial that tested on 577 patients with BRAF V600K & V600E mutation-positive metastatic or unresectable melanoma. The patients were randomized during the test to binimetinib 45 mg two times a day along with encorafenib 450 mg once a day, vemurafenib 960 mg two times a day, or encorafenib 300 mg once a day. The treatment with the combination of the drugs continued until the moment of unacceptable toxicity or disease progression.

The OS (overall survival) test that was conducted on the patients deduced that around 39 percent reduction of the overall risk of death was brought about in the patients who were receiving the combination of the drugs. BRAF is one of the most common genetic mutations that occur in metastatic melanoma (skin cancer). The patients who had been randomized to the given drug combination had the median OS of 33.6 months unlike the 16.9 months value for those who did not receive the combination treatment.