FDA approves Tafinlar (Glaxo Smith Kline) for BRAF V600E Metastatic Melanoma
The FDA has approved Tafinlar (dabrafenib), from Glaxo Smith Kline, as a single-agent oral treatment for unresectable Melanoma or Metastatic Melanoma in adult patients with BRAF V600E mutation. Tafinlar, formerly GSK 2118436, is not indicated for the treatment of patients with wild-type BRAF Melanoma.
The approval is based on results from a multicenter, international, pivotal, open-label Phase III BREAK-3 study of 250 previously untreated adult patients. It demonstrated a statistically significant increase in PFS in patients treated with dabrafenib, compared to dacarbazine: the median PFS was 5.1 months with dabrafenib compared to 2.7 months with dacarbazine. The ORR with dabrafenib was 52 percent versus 17 percent with dacarbazine.
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