GSK's Taflinar pockets breakthrough label
GlaxoSmithKline's Tafinlar garnered additional FDA attention Monday when the regulator granted the drug Breakthrough Therapy status for patients with metastatic BRAF V600E mutation-positive non-small-cell lung cancer who have already undergone platinum-containing chemotherapy.
Phase-II data helped secure the designation, which accelerates the regulatory review process. The FDA approved this same drug January 9 for use with Mekinist among patients with unresectable metastatic melanoma with BRAF V600 or V600K mutation or for treating metastatic melanoma with either of these mutations.
Tafinlar was approved last May for use as a single-agent oral therapy in treating unresectable or metastatic melanoma in patients with the BRAF V600 or V600K mutation. And this month, the FDA also sanctioned single-pill combination use of Tafinlar and Mekinist, GSK's other drug for patients whose melanoma cells have the V600E or V600K mutation in the BRAF gene.