The First FDA Approval of Two Melanoma Therapies in Combination

By Louise M. Perkins, Ph.D., MRA Chief Science Officer | 10 January 2014 | News

You may have heard this from other sources already, but we want to take a minute and explain why we’re so excited at MRA by some recent news.

This week, GlaxoSmithKline announced that it had received approval from the U.S. Food and Drug Administration (FDA) of a combination treatment for melanoma.  The agency approved the combination of two genetically-targeted drugs, dabrafenib (Tafinlar™) and trametinib (Mekinist™), for patients with metastatic or unresectable melanoma whose tumors possess either the BRAF V600E or V600K genetic mutations.

Why is this so important?

Approved Image for FB

Well, the excitement is on two fronts. On the one hand, the excitement is high because this was an accelerated approval, a type of approval which allows the FDA to expeditiously approve treatments for serious conditions that fill an unmet medical need.  This is good news for patients because it means the treatment is available to patients sooner than if it was felt to be important to wait for the final, definitive clinical trial to be completed and analyzed.

Secondly, it’s exciting because combinations of treatments are like a one-two punch, attacking the cancer from two different angles and hopefully stalling—or stopping—tumor resistance and improving patient outcomes. These treatments were approved as single agents back in the summer of 2013, and having the data that shows how and why to combine them is important for doctors and patients.

MRA and the melanoma patient community have voiced the need for more treatment options for this disease, and this approval shows that companies and the FDA are responding to this urgency.

MRA has played a critical role in funding combination approaches to fight melanoma.  We have dedicated nearly $12 million to research into this area and anticipate that this figure will increase in March, after we announce our 2014 grant awards. We’re glad to start off 2014 with a bang, and we hope this approval is only a foretaste of the exciting melanoma developments yet to come this year!

Melanoma Research FDA Combination Therapy