- Lenvatinib was developed for treatment of progressive radioiodine refractory refractory differentiated thyroid cancer.
- Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor.
- Phase III trials showed a significant, treatment-related improvement in progression-free survival (PFS) for patients using lenvatinib.
In June, Biopharma Dive reported that if this lenvatinib were to be approved, it would have the distinction of becoming the first molecular-targeted small-molecule drug developed by a Japanese pharma company.
The FDA filing is based on a placebo-controlled, phase III study with 392 patients. Because advanced thyroid cancer is so difficult to treat, having an available treatment option could potentially shift the standard-of-care. Eisai is predicting sales of $294 million by 2020.
That could be a game changer for Eisai, which is still coping with losses stemming from the patent expiration of its blockbuster Alzheimer's drug Aricept, which accounted for as much as 40% of the company's revenues in 2011.