Therapy Areas: Respiratory
The US FDA announces approval for Tafinlar and Mekinist for the treatment of BRAF-positive anaplastic thyroid cancer
7 May 2018 -

Public health company The US Food and Drug Administration Friday approved Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of anaplastic thyroid cancer (ATC), a rare, aggressive type of thyroid cancer that accounts for about 1 to 2% of all thyroid cancers.

In conjunction, the US FDA granted Priority Review and Breakthrough Therapy designation for this indication to Novartis Pharmaceuticals Corporation.

Both Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, is approved for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic) and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive).

The efficacy of Tafinlar and Mekinist in treating ATC was studied in the company's open-label clinical trial of patients with rare cancers with the BRAF V600E mutation. The data from the BRAF V600E mutation-positive, metastatic melanoma or lung cancer and results in other BRAF V600E mutation-positive rare cancers provided confidence in the results seen in patients with ATC.

This trial measured the percent of patients with a complete or partial reduction in tumor size (overall response rate). Of 23 evaluable patients, 57% experienced a partial response and 4% experienced a complete response; in 64% of the 14 patients with responses, there were no tumor growths for six months or longer, concluded the company.