GlaxoSmithKline now has the first combination oral targeted therapy for unresectable metastatic melanoma with BRAF V600 or V600K mutation. The company announced Wednesday that the FDA approved using Mekinist (trametinib) and Tafinlar (darafenib) in tandem for the condition, and as a team approach to treat metastatic melanoma with either of these mutations.
The agency approved the drug combination based on using Phase I and Phase II data under the priority review program. The drugmaker is also set to deliver Phase III results from its Combi trial at a later date.
The approval moves documented off-label use of the drugs into officially sanctioned territory. However, it may require more than physician inclination to help the combined therapy take off. Kantar Health Director Gordon Gochenauer noted in the consulting firm’s blog last fall that the National Comprehensive Cancer Network would have to agree to provide reimbursement because the combined drug therapy would drive up advanced melanoma treatments to about $16,000 a month, with a typical treatment lasting around a year.
