FDA Breakthrough status for combo therapy for stage III BRAF V600 mutation-positive melanoma patients

The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection.

Tafinlar in combination with Mekinist is in development by Swiss pharma giant Novartis (NOVN: VX) to become the first adjuvant treatment specifically for melanoma patients with a BRAF V600 mutation. Market reaction to the news was muted, with Novartis shares gaining just 0.77% to 85.10 Swiss francs in morning trading.

The FDA approved Tafinlar+Mekinist as a combination therapy for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation in June this year. The combination received approval for this indication in Europe in June. The combo product, to which Novartis gained rights as part of its three-part swap with UK pharma major GlaxoSmithKline (LSE: GSK) in 2015, generated sales of $216 million in the second quarter of this year.