Regulatory Affairs

Novartis’ Tafinlar/Mekinist combo gets FDA nod for anaplastic thyroid cancer

PBR Staff Writer Published 07 May 2018

Novartis Pharmaceuticals has secured approval from the US Food and Drug Administration for its Tafinlar (dabrafenib) and Mekinist (trametinib) combination therapy to treat anaplastic thyroid cancer (ATC).

The approval is for patients in whom the tumor cannot be removed by surgery or has spread to other parts of the body, and has the abnormal gene, BRAF V600E.

ATC is a rare, aggressive form of thyroid cancer and the FDA approval marks the first therapy to be indicated for the condition. This condition makes up nearly 1 to 2% of all thyroid cancers, said FDA.

It is now the third cancer with the BRAF V600E mutation that the Tafinlar/Mekinist combination has been approved for treatment.

Previously, Tafinlar and Mekinist were approved by the US regulator for use, alone or in combination, for the treatment of BRAF V600 mutation-positive metastatic melanoma.

The two drugs have also been approved in the US as a combination therapy for BRAF V600E mutation-positive, metastatic non-small cell lung cancer.

FDA center for drug evaluation and research office of hematology and oncology products acting director Richard Pazdur said: “This approval demonstrates that targeting the same molecular pathway in diverse diseases is an effective way to expedite the development of treatments that may help more patients.”

The latest approval of the Tafinlar and Mekinist combination for ATC was based on the results of an open-label clinical trial featuring patients with rare cancers with the BRAF V600E mutation.

The FDA said that data collected from trials in BRAF V600E mutation-positive, metastatic melanoma or lung cancer along with results shown in other BRAF V600E mutation-positive rare cancers gave confidence in the results shown across ATC patients.

Out of 23 evaluable patients in the trial, 57% had a partial response while 4% had a complete response. Further, in nine of the 14 patients with responses, there were no significant growths in tumor observed over a period of six months or longer, said FDA.


Image: Novartis headquarters in Basel, Switzerland. Photo: courtesy of Novartis AG.