FDA approves Eisai's thyroid cancer treatment Lenvima

The FDA announced Friday approval of Eisai's Lenvima (lenvatinib) for the treatment of progressive, differentiated thyroid cancer (DTC) in patients whose disease progressed despite receiving radioactive iodine therapy. Richard Pazdur, director of the Office of Hematology and Oncology Products in the agency's Center for Drug Evaluation and Research, commented "the development of new therapies to assist patients with refractory disease is of high importance," with the regulator approving Lenvima ahead of its target goal date of April 14.

The FDA noted that the clearance, which occurred under its priority review programme, was supported by data from a study of 392 patients with progressive, radioactive iodine-refractory DTC. In the SELECT study, the results of which were recently published in the NEJM, treatment with Lenvima was associated with a median progression-free survival of 18.3 months, versus 3.6 months for placebo-treated patients. In addition, 65 percent of patients in the Lenvima arm experienced tumour shrinkage, compared to 2 percent for the placebo group.

Filings for the oral tyrosine kinase inhibitor for the treatment of radioactive iodine-refractory DTC remain under review in Japan, as well as in Europe, where it has been awarded orphan drug status. Eisai has also submitted the therapy for approval in South Korea. A company executive recently suggested that if approved in further indications, such as liver and kidney cancer, Lenvima could generate annual sales of more than $1 billion by 2020.

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