In an important win for GlaxoSmithKline's R&D division, the FDA today announced that it has approved a pair of genetically targeted melanoma drugs, dabrafenib and trametinib, from the company, along with a diagnostic test that can be used to identify the patients most likely to respond to the treatments.
GlaxoSmithKline has stepped up its late-stage program to advance a combo of targeted cancer drugs against deadly skin cancer, with a new study to see whether its experimental BRAF and MEK inhibitors can keep melanoma from coming back after surgeries.
The drug giant's quick work with the experimental drugs shows how fast a company can get to a new drug application with treatments for well-defined groups of patients and impressive clinical data.
Look out Roche. Because here comes GlaxoSmithKline touting upbeat results of two Phase III studies of the targeted drugs dabrafenib and trametinib in patients with metastatic melanoma.
Data from the small mid-stage trial provide early evidence that GSK's two-drug combo could have an edge over Roche's approved melanoma drug Zelboraf.
ASCO is releasing a mountain of data on cancer studies, and some of the biggest names in the business will be angling for star billing on some closely watched therapies.