Please login to the form below

Not currently logged in
Email:
Password:

Eisai's Lenvima gets FDA priority review for kidney cancer

The oncology treatment could now be approved in the US before the summer
Eisai

The FDA has started a priority review of Eisai's Lenvima as a treatment for the most common form of kidney cancer, setting up a possible approval before the summer.

Lenvima (lenvatinib mesylate) was approved in the US and Europe to treat some forms of thyroid cancer last year, but a green light in advanced renal cell carcinoma (RCC) would make the drug available to a much broader patient population.

It is under review as a combination therapy for adults with advanced or metastatic RCC - alongside Novartis' mTOR inhibitor Afinitor (everolimus) - in patients who have previously been treated with at least one VEGF-targeted therapy. These include Novartis' Votrient (pazopanib), Bayer/Onyx Nexavar (sorafenib), Pfizer's Sutent (sunitinib) or Roche's Avastin (bevacizumab).

The drug is a multiple receptor tyrosine kinase (RTK) inhibitor with broad activity against several VEGF and FGF subtypes and factors involved in cancer cell proliferation. It has been awarded breakthrough status as a treatment for metastatic RCC by the FDA.

RCC is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths worldwide each year, is associated with a five-year survival rate of around 12%.

The area has a pressing need for new treatment options because while most first-line therapies provide a short-term benefit they eventually lose their efficacy.

Last year, Eisai reported phase II trial results showing that lenvatinib given alongside everolimus extended progression-free survival by around nine months compared to everolimus given alone, along with improvements in overall survival and objective response rate.

If approved, Lenvima will join a number of other new drugs that promise to provide additional treatment options for RCC patients, including Bristol-Myers Squibb's PD-1 inhibitor Opdivo (nivolumab) which could be approved within the next few months.

The action date for Lenvima's RCC application, as set by the Prescription Drug User Fee Act (PDUFA), is May 16 according to Eisai, which hopes to grow the product into a $1bn brand by 2020.

The drug is also in trials involving patients with liver cancer (hepatocellular carcinoma) - with a filing due later this year - and in combination with Merck & Co's PD-1 inhibitor Keytruda (pembrolizumab) in a range of cancer types.

Article by
Phil Taylor

19th January 2016

From: Research

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Aptus Health

Aptus Health is dedicated to advancing health engagement. The company offers end-to-end digital health engagement solutions spanning all areas of...

Latest intelligence

Mapping content strategies to pharma lifecycle management
In these tough economic times, we should be ramping up our pharma lifecycle management (LCM) strategies. These are well-established strategies for managing and extending the commercial value of products. So...
Back from the future – innovation for pharma
After 5 days of seeing amazing innovations, having discussions about the future of medicine and the practicalities of living on Mars. Plus listening to inspiring speakers from fighter plane-flying physicians...
Cost containment and the German market
The healthcare system’s budget limitations will face further pressure from challenges such as personalised medicine...

Infographics