GlaxoSmithKline’s Tafinlar Receives FDA ‘Breakthrough’ Status
GlaxoSmithKline’s (GSK) Tafinlar (dabrafenib) was yesterday granted ‘breakthrough’ status by the US Food and Drug Administration (FDA), meaning it will be fast tracked through the US regulatory system.
The US regulatory body granted authorisation to accelerate Tafinlar’s development as a drug for metastatic BRAF V600E mutation-positive non-small cell lung cancer (NSCLC), in patients who have had at least one prior line of platinum-containing chemotherapy.
Lung cancer is the second most common cancer, and is the leading cause of cancer-related death globally. Recent advances into the understanding of tumour biology have identified genetic mutations that can drive malignant cell growth and tumour proliferation in non-small cell lung cancer.
The decision to grant ‘breakthrough’ status was based on the interim efficacy and safety data from an ongoing Phase II clinical study of Tafinlar in patients with the mutation, which is believed to affect roughly 2% of those with NSCLC.
While no complete responses had yet been observed, findings from the clinical trial showed that 40% of patients had a partial response, 20% were considered to have stable disease and 30% had progressive disease.
Tafinlar has not previously been approved or licensed anywhere in the world for use in this setting, but the FDA have recently approved the drug, in combination with Mekinist (trametinib), to treat patients with unresectable or metastatic melanoma who have BRAF V600E or V600K mutations.