FDA grants priority review status to Eisai’s sNDA for anticancer drug lenvatinib
The US Food and Drug Administration (FDA) has granted priority review status to the supplemental new drug application (sNDA) submitted by Eisai for its anticancer agent lenvatinib mesylate to treat advanced or metastatic renal cell carcinoma.
A prescription drug user fee act action date of 16 May 2016 has been assigned, six months after the submission of the sNDA.
The sNDA was based on a phase II clinical trial that compared the safety and efficacy among three groups.
The groups included a combination of lenvatinib (18mg) plus everolimus (5mg), lenvatinib alone (24mg) and everolimus alone (10mg) in advanced or metastatic renal cell carcinoma.
Under the study, an extension in progression free survival (PFS) was demonstrated compared to the everolimus alone group.
In addition, the lenvatinib alone group showed an extension in PFS compared to the everolimus alone group.
Both the lenvatinib plus everolimus group and the lenvatinib alone group demonstrated an improvement in objective response rate compared to the everolimus alone group.
Lenvatinib has also secured a breakthrough therapy designation from the FDA. Eisai has also submitted an application in Europe seeking approval for use in the treatment of renal cell carcinoma.
The drug is already available under the brand name Lenvima in the US, Japan and Europe to treat refractory thyroid cancer.
It is expected that there are about 58,000 kidney cancer patients in the US. Renal cell carcinoma consists of over 90% of all malignancies of the kidney.
Published 19 January 2016http://processandproduction.pharmaceutical-business-review.com/