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news.The US Food and Drug Administration (FDA) has granted approval for Eisai's receptor tyrosine kinase inhibitor Lenvima (lenvatinib) to treat locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).
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The approval was based on data from a multicenter, randomized, double-blind, placebo-controlled Phase III SELECT trial.
A total of 392 patients were included in the trial, in which Lenvima showed a statistically significant progression-free survival (PFS) prolongation and response rate in patients with progressive, differentiated thyroid cancer who had become refractory to radioactive iodine (RAI) therapy.
FDA Center for Drug Evaluation and Research director of the Office of Hematology and Oncology Products Richard Pazdur said: "The development of new therapies to assist patients with refractory disease is of high importance to the FDA.
"Today’s approval gives patients and healthcare professionals a new therapy to help slow the progression of DTC."
The results from the Phase III trial also showed that patients treated with Lenvima lived a median of 18.3 months without their disease progressing, compared to a median of 3.6 months for participants who received a placebo.
ThyCa: Thyroid Cancer Survivors’ Association executive director Gary Bloom said: "The incidence of thyroid cancer has been increasing globally over the last 50 years and for patients with thyroid cancer that progresses following surgery and radioactive iodine treatment, the prognosis is often poor.
"We are excited about the approval of LENVIMA, which may help address an unmet need as there are limited treatment options for patients with this type of thyroid cancer."