Eisai has presented more positive data on its potential blockbuster lenvatinib in a late-stage thyroid cancer trial.
Previously-presented results from the Phase III SELECT trial in the treatment of radioiodine-refractory differentiated thyroid cancer demonstrate that lenvatinib significantly extended progression-free survival by a median of 14.7 months. Now, further results from the study, published in the New England Journal of Medicine, show that the oral multiple receptor tyrosine kinase inhibitor, taken once-daily, improved response rate in 64.8% for people with RR-DTC compared with just 1.5% for placebo.
Adverse effects were managed with dose reductions and standard interventions, but were greater with lenvatinib, and include six treatment-related deaths.
In October, the US Food and Drug Administration granted a priority review to lenvatinib and assigned a Prescription Drug User Fee Act action date of April 14. It has also been granted an accelerated assessment by the European Medicines Agency.
