FDA approves Novartis combo in rare thyroid cancer subtype
pharmafile | May 8, 2018 | News story | Manufacturing and Production, Sales and Marketing | Cancer, FDA, Tafinlar, mekinist, thyroid cancer
The FDA has announced its decision to approve the use of Novartis’ combination of Tafinlar (dabrafenib) and Mekinist (trametinib) in the treatment of BRAF V600E mutation-positive anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has metastasised.
The US regulator based its decision on data which showed that 57% of 23 evaluable trial participants experienced partial response to the treatment, while 4% experienced complete response. Of these 14 patients exhibiting a response, 64% observed at least six months of progression-free survival.
Both combo drugs are already approved, alone or in combination, for the treatment of BRAF V600 mutation-positive metastatic melanoma, as well as BRAF V600E mutation-positive, metastatic non-small cell lung cancer when administered together.
Anaplastic thyroid cancer is very rare, accounting for around 1-2% of all US thyroid cancer cases, and is expected to be attributable for 2,060 deaths in the nation in 2018, while 53,990 new cases will emerge in the same year, according to the National Institutes of Health.
“This is the first FDA-approved treatment for patients with this aggressive form of thyroid cancer, and the third cancer with this specific gene mutation that this drug combination has been approved to treat,” said Dr Richard Pazdur, Director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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.”
Matt Fellows
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