Eisai gets U.S. kidney cancer nod for Lenvima combo with Afinitor

FDA sign

Tokyo-based Eisai said its U.S. unit won a regulatory nod on an additional indication for the combination therapy of Lenvima (lenvatinib) and Novartis’ ($NVS) cancer drug Afinitor (everolimus) to treat advanced renal cell carcinoma.

Lenvima and Afinitor were jointly granted a review in January to treat advanced renal cell carcinoma (RCC)--a form of kidney cancer--as a second-line treatment in patients who had previously failed VEGF therapy.

The U.S. RCC market is however a crowded one with some big blockbusters, including Pfizer’s ($PFE) Sutent (sunitinib) and follow-up Inlyta (axitinib), as well as Bayer’s Nexavar (sorafenib).

But Eisai is confident in its drug and combo offering, saying in a release: “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.”

Last year, Eisai also won U.S. FDA and European approvals for Lenvima for the treatment of a certain form of thyroid cancer.

An Eisai exec said at the time that the push was on for further indications in liver, kidney, lung and endometrial cancers that if successful could see sales for the therapy reach $1 billion annually by 2020. That type of push could see it become the next Nexavar, which also has licenses in certain liver and thyroid cancers.

The latest indication approval, according to the release, relied on a Phase II clinical study comparing safety and efficacy of Lenvima alone, and in combination with Afinitor, in patients with unresectable advanced or metastatic renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy.

Eisai said there are around 58,000 patients in the U.S. with renal cell carcinoma. Afinitor currently has licenses for breast and pancreatic cancers, while Lenvima had only been approved in differentiated thyroid cancer before today’s announcement.

- here's the release