Eisai files NDA for lenvatinib in Japan
- This is the first marketing application for lenvatanib.
- Lenvatanib was developed for the treatment of advanced thyroid cancer. If approved, this drug will become the first molecular-targeted small molecule agent developed by a Japanese pharmaceutical company.
- Eisai forecasts sales of $294 million by 2020 for lenvatanib.
Thyroid cancer is generally responsive to treatment in early stages, but very difficult to treat as it progresses. A phase III study evaluated lenvatanib in patients with radioactive-refractory differentiated thyroid cancer and radiographic evidence of disease progression within the prior 13 months. Lenvatanib achieved a statistically significant improvement in progression-free survival, compared with placebo.
Lenvatanib has been grated orphan drug status in Japan due to the unmet need associated with advanced thyroid cancer. Eisai plans to submit regulatory applications in the US and Europe within the next few weeks.