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Tafinlar (Debrafenib) Receives FDA ‘Breakthrough’ Designation for Lung Cancer

Drug is currently approved for melanoma (January 13)

The FDA has granted a “breakthrough therapy” designation for Tafinlar (dabrafenib, GlaxoSmithKline) for the treatment of patients with metastatic BRAF V600E mutation-positive non–small-cell lung cancer (NSCLC) who have received at least one prior line of platinum-containing chemotherapy. Dabrafenib is not approved for use in this treatment setting.

The new designation was based on interim efficacy and safety results from an ongoing phase II study of oral dabrafenib in 25 patients who had NSCLC with the BRAF V600E mutation and who had received at least one course of chemotherapy. The interim results were presented at the 2013 American Society for Clinical Oncology Annual Meeting.

A “breakthrough therapy” designation is intended to expedite the development and review of drugs to treat serious or life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may offer substantial improvement on at least one clinically significant endpoint compared with available therapies.

Lung cancer is the second most common cancer in both men and women and is the leading cause of cancer-related death worldwide. Recent advances in the understanding of tumor biology have identified genetic mutations, such as a mutation in the BRAF protein, that can drive malignant cell growth and tumor proliferation in NSCLC. It is estimated that the BRAF V600E mutation targeted by dabrafenib is present in approximately 2% of patients with NSCLC.

Tafinlar (dabrafenib) is currently indicated for the treatment of melanoma.

Source: GlaxoSmithKline; January 13, 2014.

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