FDA approves Lenvima for Thyroid Cancer-Eisai

The FDA has approved Lenvima (lenvatinib), from Eisai, for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC). Lenvima was approved following a priority review by the FDA. Approval is based on results from the pivotal Phase III SELECT clinical trial, recently published in the New England Journal of Medicine, in which treatment with Lenvima resulted in a highly statistically significant improvement in progression-free survival and a high overall response rate in patients.

Serious risks seen in patients were hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, proteinuria, renal failure and impairment, gastrointestinal perforation and fistula formation, QT interval prolongation, hypocalcemia, reversible posterior leukoencephalopathy syndrome, hemorrhagic events, impairment of exogenous thyroid suppression and embryofetal toxicity. The most common adverse reactions were hypertension, fatigue, diarrhea and arthralgia/myalgia.