US regulators have approved Eisai’s Lenvima (lenvatinib) for the most common form of thyroid cancer.
The drug can be now be used in the US to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease has progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).
FDA clearance, which comes following a priority review and a few months ahead of schedule, was issued on the back of data showing that Lenvima-treated patients had progression-free survival of 18.3 months versus 3.6 months for those taking a placebo.
Also, 65% of patients taking Lenvima saw a reduction in tumour size, compared to 2% in the placebo arm.
The oral multiple receptor tyrosine kinase inhibitor is also being studied for hepatocellular carcinoma (Phase III), non-small cell lung cancer (Phase II) and other solid tumour types.