WASHINGTON, March 18 (UPI) — A drug combination approved last year by the U.S. Food and Drug Administration may have a greater effect for men with melanoma than previously reported, according to a new analysis of clinical trial data.
The drugs dabrafenib and trametinib were shown in the trial to increase survival time for women with melanoma, but no benefit was seen for men until the drug’s manufacturer submitted additional data during the comment period on the agency’s approval.
Researchers at the German Institute for Quality and Efficiency in Health Care analyzed data from the COMBI-v study, a randomized phase 3 study with 704 patients that showed an overall increase in survival among patients given the combination therapy rather than a single drug.
The study also showed men had fewer side effects from the drugs, which are used for advanced metastatic melanoma. The overall increase in survival, however, was not quantifiable for men.
Based on a sensitivity analysis of additional data on morbidity submitted to the FDA, researchers said in a press release they detected “a hint of a considerable added benefit” for men from the drug combination.
The two drugs, both of which act differently against BRAF-mutation positive melanoma, were approved separately by the FDA in 2013. The FDA gave accelerated approval for their combined use in 2015.