On January 14, 2014 the FDA declared a Breakthrough Therapy designation for Dabrafenib, also known as the brand name Tafinlar as a single agent to treat certain types of lung cancer, specifically for the treatment of metastatic BRAF V600E mutation-positive non-small cell lung cancer. The target patient population should have already previously received one line of platinum-containing chemotherapy.
GlaxoSmithKline, the company who markets Tafinlar, excitedly announced the news following earlier good news regarding Dabrafenib. On January 10, 2014 the FDA announced the accelerated approval for a drug combination consisting of Dabrafenib (Tafinlar) and Trametinib (Mekinist) to treat patients with specific types of unresectable melanoma.
The FDA based their latest decision to award a Breakthrough Therapy designation to Dabrafenib based on results presented from a Phase 2 study at the 2013 American Society for Clinical Oncology Annual Meeting. The Phase 2 study, which is currently ongoing, was a single arm, open label trial that included 20 patients, who were evaluated for efficacy of Dabrafenib, and 25 patients, who were evaluated for the safety of this formidable drug. Clinical trial participants received 150 milligrams of Dabrafenib twice daily and the median duration of treatment was 84 days. While no complete response was found among the 20 patients evaluated for the efficacy of Dabrafenib, 8 patients achieved a partial response. Additionally, 4 patients demonstrated a stable disease status. As the response rate goal of this study was 40 percent, and the disease control rate was 60 percent, results demonstrating positive clinical activity have been presented in this ongoing study. Adverse effects did plague 98 percent of participants, although the most commonly reported side effects were minor, like fatigue and nausea.
Dabrafenib is a powerful treatment that is proving to have a fighting chance against BRAF-mutant melanoma. With lung cancer claiming top spot on the list of causes of cancer deaths, the advancements regarding specialized drugs , like Dabrafenib, to treat the variety of cases is essential. Roughly 2 percent of the patient population diagnosed with non-small cell lung cancer has the BRAF V600E mutation.
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