FDA approves Pfizer cancer drug Inlyta
pharmafile | January 30, 2012 | News story | Sales and Marketing | Nexavar, Pfizer, Sutent, rcc, renal cell carcinoma
Pfizer’s kidney cancer drug Inlyta has gained US approval for second line treatment for the disease.
Inlyta (axitinib) is now licensed to treat patients with advanced renal cell carcinoma (RCC) after the failure of one prior systemic therapy.
The drug is also currently under review by the European Medicines Agency for use in patients who have failed on an established treatment.
A multi kinase inhibitor targets VEGF receptors 1, 2 and 3, Inlyta was shown to outperform Bayer’s Nexavar (sorafenib) in a phase III head-to-head trial published last year.
Inlyta produced a median PFS of 6.7 months compared to 4.7 months in Nexavar patients.
The drug will add to Pfizer’s portfolio of RCC drugs, Sutent (sunitinib) and Torisel (temsirolimus).
The drugs made $1.1 billion and $370 million respectively in 2010, and are both licensed to treat advanced forms of RCC, whilst Sutent is also approved to treat rare types of pancreatic and stomach cancers.
But Inlyta will be up against six other drugs for advanced kidney cancer, and analysts say it will struggle to gain market share, and estimate peak annual sales of around $600 million.
Pfizer said the average monthly cost of Inlyta is just under $8,900, roughly the same cost as other treatments for advanced kidney cancer.
Richard Pazdur, director of haematology and oncology products at the FDA, said: “This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005.
“Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options.”
Recently approved drugs for the treatment of kidney cancer in the US include: Bayer’s Nexavar in 2005, followed closely by Pfizer’s Sutent and Torisel, Novartis’ Afinitor, Roche’s Avastin and most recently, GlaxoSmithKline’s Votrient.
Analysts at Decision Resources believe that Sutent and Votrient will be the market leaders by 2019, which are both approved as first line treatments.
Inlyta is currently being investigated in a mid-stage trial as a first-line treatment for the disease, and is also in phase II for hepatocellular carcinoma (HCC).
Ben Adams
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