FDA grants GSK ‘priority review’ on melanoma treatment

18-Sep-2013 - Last updated on 19-Sep-2013 at 10:46 GMT

The Food and Drug Administration has given GSK a ‘priority review’ on the work it’s been doing on a melanoma treatment, which if approved, will see for the first time, the dual use of ‘Tafinlar’ in the treatment of skin cancer.

The news of a more efficacious treatment comes at a time when skin care experts are urging for more to be done to prevent, educate or help the general population from the risk of sun and UV exposure, as those diagnosed with skin cancer is revealed to be up to 160,000 people worldwide each year.

Tafinlar also known as 'dabrafenib' and 'Mekinist' or 'trametinib' has already been approved to treat a certain type of metastatic melanoma when used separately, but now GSK believes they will have a longer-lasting effect if used together.

By combining Tafinlar with Mekinist, which works in a different way, GSK say the hope is that the cancer will be held at bay for longer, and if approved, will be used to treat melanoma that cannot be removed by surgery or which has spread to other organs.

The company has revealed this week that the FDA has set a target date of Jan. 8, 2014 for the review of Mekinist and Jan. 9 for the Tafinlar supplement.

Skin care experts frequently express Melanoma concerns

The call from skin care experts to address the dangers of melanoma intensified last April after a study by Yale researchers revealed that more than a quarter of survivors do not use sunscreen when outside for more than an hour and more than 2 percent still use tanning beds.

As such, Anees B. Chagpar, M.D., M.P.H., associate professor of surgery at Yale School of Medicine, has recommended the data is used to educate the general population, as the results revealed that only 17.2 percent of Americans will always use sunscreen and 5.5 percent still use tanning beds.

Chagpar and colleagues evaluated data from the 2010 National Health Interview Survey, presenting it at the AACR Annual Meeting 2013, held in Washington, D.C., focusing on data collected on self-reported history of melanoma, sun protection practices and indoor tanning.

Of 27,120 adults, 171 had a prior history of melanoma. Researchers found that compared with those individuals who reported no history of melanoma, survivors were more likely to cover themselves, stay in the shade or wear sunscreen if out on sunny day for more than an hour.

"We now know that a significant proportion of melanoma survivors still could be doing better. This study speaks to what we could do to educate melanoma survivors on how to prevent recurrence," Chagpar concluded.