Eisai submitted applications to the FDA and European Medicine Agency for its liver cancer drug lenvatinib mesylate.
Here's what you should know:
1. The FDA already awarded lenvatinib orphan drug status.
2. Eisai conducted a multicenter, open-label, randomized, global phase III trial comparing lenvatinib to standard hepatocellular carcinoma treatment, sorafenib.
3. Lenvatinib met its primary endpoint and its overall survival rate was as effective as sorafenib.
Considering secondary endpoints, lenvatinib was significantly more effective than sorafenib in progression free survival, time to progression and objective response rate.
4. Lenvatinib had five common adverse events associated with it:
- Hypertension
- Diarrhea
- Decreased appetite
- Weight loss
- Fatigue
5. The FDA already approved Lenvatinib as a refractory thyroid cancer treatment. The FDA also approved the drug as a joint therapy for renal cell carcinoma.