16 May 2016 - Eisai announced today that its U.S. subsidiary Eisai Inc. has received approval from the U.S. FDA for an additional indication for Eisai’s in-house developed novel anti-cancer agent Lenvima (lenvatinib mesylate) in combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy.
This is the only combination regimen to significantly prolong progression-free survival when compared with a standard of care in patients with advanced renal cell carcinoma following prior anti-angiogenic therapy.
Lenvima was designated as a Breakthrough Therapy by the FDA and also received a Priority Review, with approval obtained approximately six months after application submission.
For more details, go to: http://www.eisai.com/news/enews201633pdf.pdf