- Under its Priority Review process, the FDA approves Eisai's (OTCPK:ESALF)(OTCPK:ESALY) Breakthrough Therapy-tagged Lenvima (lenvatinib), in combination with Novartis' (NYSE:NVS) Afinitor (everolimus), for the treatment of patients with advanced renal cell carcinoma who have been previously treated with an anti-angiogenic therapy.
- The data supporting the approval was generated in a Phase 2 clinical trial called Study 205. Patients receiving Lenvima plus Afinitor experienced a median increase in progression-free survival of over 165% (14.6 months versus 5.5 months) compared to those receiving Afinitor alone. The combination regimen also showed a 63% reduction in the risk of disease progression or death (hazard ratio: 0.37) compared to Afinitor as monotherapy. Other endpoints favoring the combination were objective response rate (37% versus 6%) and median overall survival (25.5 months versus 15.4 months).
- The most common treatment-emergent serious adverse events were renal failure (11%), dehydration (10%); anemia (6%), thrombocytopenia (low blood platelets) (5%), diarrhea (5%), vomiting (5%) and dyspnea (difficulty breathing) (5%).
- Lenvatinib is a receptor tyrosine kinase inhibitor that inhibits multiple VEGF (vascular endothelial growth factor) receptors which play key roles in the growth of cancer cells. Interfering with the receptors' activity slows the progression of cancer by restricting the blood supply to the tumors (antiangiogenesis).
- The FDA first approved Lenvima in February 2015 for treatment-resistant thyroid cancer.