Glaxo Smith Kline files NDA and MAA for dabrafenib in Metastatic Melanoma patients

Glaxo Smith Kline has filed a New Drug Application to the FDA for dabrafenib for the treatment of patients with unresectable or Metastatic Melanoma with BRAF V600 mutation as detected by an FDA-approved test. The company has also filed a Marketing Authorisation Application to the EMA for dabrafenib for treating adult patients with the same mutation. This follows positive results from the BREAK 3 Phase III trial of dabrafenib which shows treatment reduced the risk of disease progression or death by 70% compared to chemotherapy. The median Progression free survival was 5.1 months in the dabrafenib arm compared with 2.7 months in the dacarbazine arm.