Eisai has filed a new drug application with the U.S. Food and Drug Administration (FDA) for lenvatinib for the treatment of patients with progressive radioiodine-refractory, differentiated thyroid cancer. Lenvatinib was granted orphan drug status by the FDA in February 2013.
The new drug application filing is based on the phase 3 double-blind, randomized, placebo-controlled SELECT study, which showed that lenvatinib delayed disease progression by 18.3 months compared with 3.6 months in the placebo group. In addition, 65% of patients taking lenvatinib experienced partial responses and 2% attained a complete response.
The study also found that lenvatinib caused several adverse effects, including hypertension, diarrhea, fatigue, decreased appetite, nausea, and vomiting.
Lenvatinib is a tyrosine kinase inhibitor that targets VEGFR1-3, FGFR1-4, PDGFR-β, KIT, and RET. If approved, lenvatinib would most likely be administered orally once daily as a 24 mg dose to patients whose differentiated thyroid cancer is 131I-refractory or -resistant following external beam radiotherapy or radiofrequency ablation.
Another targeted tyrosine kinase inhibitor, sorafenib, was approved by the FDA in November 2013 for radioiodine-resistant differentiated thyroid cancer.
Eisai has filed its anticancer agent lenvatinib with regulators on both sides of the Atlantic. Specifically the drug has been submitted as a treatment for progressive radioiodine-refractory, differentiated thyroid cancer.
The filings, which come after a Japanese submission in June, is based on a 392-patient Phase III study which showed that lenvatinib achieved a statistically significant improvement in progression-free survival.
Related Links Eisai’s lenvatinib to get speedy review in Europe Lenvatinib has orphan drug designation for thyroid cancer in the USA, Japan and in Europe, where it has granted an accelerated assessment by the European Medicines Agency, as a new medicine expected to be of major public health interest.