The FDA plans January review for a combination treatment from GlaxoSmithKline (NYSE: GSK) that targets skin cancer that is either inoperable or has spread to organs.
In an announcement issued Monday, GSK said the FDA plans a “priority review” of its supplemental new drug applications for the combined used of Tafinlar and Mekinist which would be for use in adult patients.
The FDA’s decision is based on a review of Phase I and II clinical studies.
The treatment is also under review by regulatory officials in Europe.
GSK operates its North American headquarters in Research Triangle Park.
On Friday, GSK received a “breakthrough” designation from the FDA for a leukemia treatment.
[GSK ARCHIVE: Check out more than a decade of GSK stories as reported in WRAL Tech Wire.]