FDA grants Eisai’s Lenvima priority review for kidney cancer
pharmafile | January 19, 2016 | News story | Manufacturing and Production | Breakthrough Therapy Designation, Eisai, FDA, Kidney cancer, Lenvima, lenvatinib, priority review, renal cell carcinoma
The FDA has accepted Eisai’s supplemental New Drug Application (sNDA) for its anti-cancer agent Lenvima for use in the treatment of advanced or metastatic renal cell carcinoma, and granted Priority Review status.
Priority Review is intended to help speed the approval process for drugs in areas of clinical unmet need, and in the case of Eisai’s drug, will mean a decision by 16 May 2016, six months after the sNDA was submitted. Lenvima (lenvatinib) has also received a Breakthrough Therapy designation from the FDA.
Eisai has submitted an application in the same indication to the EMA, and intends to discuss further steps regarding submission strategies with the regulatory authorities in its native Japan.
The sNDA is backed by data from a Phase II clinical study (Study 205), which compared the safety and efficacy among three groups including a combination of Lenvima (18 mg) plus Afinitor (everolimus) (5 mg), Lenvima alone (24 mg) and everolimus alone (10 mg), in people with unresectable advanced or metastatic renal cell carcinoma who had already had one prior therapy.
The group who received the combination of Lenvima plus everolimus demonstrated a significant extension in progression free survival (PFS), the study’s primary endpoint, compared to the everolimus alone group. Additionally, the Lenvima alone group demonstrated an extension in PFS compared to the everolimus alone group.
The number of patients with kidney cancer in the United States is estimated at 58,000, and 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 is molecular targeted drug therapy. However with low five-year survival rates, this remains a disease with significant unmet medical need.
Lenvima is already approved in the US, Japan and Europe for use in the treatment of refractory thyroid cancer. Eisai says it is committed to exploring the potential clinical benefits of the drug in additional indications.
Joel Levy
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