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.