FDAnews Drug Daily Bulletin

GSK’s Tafinlar Receives Breakthrough Therapy for BRAF NSCLC

Jan. 16, 2014

The FDA has granted GlaxoSmithKline breakthrough therapy designation for Tafinlar for patients with metastatic BRAF V600-E mutation-positive non-small-cell lung cancer who have already undergone one treatment with platinum-containing chemotherapy. Approximately two percent of patients with NSCLC have this mutation, the company says.

The agency’s decision was based on interim results from an ongoing Phase II trial of oral Tafinlar (dabrafenib) in 25 patients.

The breakthrough designation is designed to speed up development and review of drugs that that meet at least one clinical endpoint showing significant improvement over existing therapies. The designation entitles sponsors to more substantial FDA advice through the development process.

The FDA last week approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for unresectable metastatic melanoma. — Lena Freund

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