Eisai has announced that the U.S. Food and Drug Administration (FDA) approved the company’s receptor tyrosine kinase inhibitor LENVIMA (lenvatinib) 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, which is designated for drugs the FDA believes have the potential to provide a significant improvement in the treatment of a serious condition. LENVIMA demonstrated 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.
“In the pivotal Phase 3 SELECT clinical trial, recently published in the New England Journal of Medicine, treatment with LENVIMA resulted in a highly statistically significant improvement in progression-free survival and a high overall response rate in patients with locally recurrent or metastatic, progressive, RAI-refractory DTC,” said Lori J. Wirth, M.D., study investigator and medical director of the Center for Head and Neck Cancers at the Massachusetts General Hospital. “The thyroid cancer community welcomes an agent that offers a significant, effective option for the treatment of differentiated thyroid cancer in patients who have progressed after becoming refractory to RAI therapy.”
“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,” said Gary Bloom, Executive Director of ThyCa: Thyroid Cancer Survivors’ Association, Inc. “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.”