Eisai’s Lenvima receives Breakthrough Therapy designation for renal cell carcinoma

29 July 2015  •  Author: Victoria White

Eisai has received a Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its in-house developed novel anticancer agent Lenvima for the potential indication of advanced and/or metastatic renal cell carcinoma.


The Breakthrough Therapy designation is intended to expedite development and review of drugs for serious or life-threatening conditions.

Lenvima plus everolimus demonstrated a significant extension in progression free survival

This Breakthrough Therapy designation was based on the results of a Phase II clinical trial (Study 205) of Lenvima in advanced or metastatic renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy. From the results of the study, the combination of Lenvima plus everolimus demonstrated a significant extension in progression free survival (PFS), the study’s primary endpoint, compared to everolimus alone. Additionally, Lenvima alone demonstrated an extension in PFS compared to everolimus alone. Both the lenvatinib plus everolimus group and the lenvatinib alone group showed an improvement in objective response rate compared to the everolimus alone group. Furthermore, an updated analysis carried out in December 2014 suggested that Lenvima plus everolimus extends overall survival compared to everolimus alone.

The number of patients with kidney cancer in 2012 was estimated to be approximately 338,000 worldwide. Renal cell carcinoma comprises more than 90% of all malignancies of the kidney. For advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment method is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical needs.

Eisai has shared the results of Study 205 with regulatory authorities to discuss further steps regarding potential submission strategies for an indication covering renal cell carcinoma.

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