The European Commission (EC) has approved Pfizer's kidney cancer drug Inlyta for use in adults with advanced renal cell carcinoma.
Inlyta (axitinib) is now available in Europe after prior treatment with Pfizer's own Sutent (sunitinib) or a cytokine has failed.
It opens up a potentially lucrative new market for Pfizer, with incidences of renal cell carcinoma in Europe estimated to at 102,000 people per year.
Many patients can be resistant to treatment, however, and between 40 and 65 per cent of patients worldwide whose disease progresses following first-line therapy go on to receive a second-line treatment.
"Inlyta offers physicians and their patients with advanced kidney cancer a new treatment option following prior treatment with sunitinib or a cytokine,” said Dr Bernard Escudier, head of the immunotherapy unit, department of medical oncology, Institut Gustave Roussy, France, and one of the investigators involved in Inlyta clinical trials.
The decision follows a recommendation from the European Medicines Agency (EMA) in May, 2012, after the drug demonstrated it was able to prolong life in patients with advanced renal cell carcinoma for longer than those treated with the currently available second-line treatment Bayer/Onyx' Nexavar (sorafenib).
Inlyta, which is already available in the US having been approved by the Food and Drug Administration (FDA) in January, 2012, has been predicted to reach blockbuster sales at its peak and bring in $500m within its first three years.
The latest approval will be welcome news for Pfizer following the phase III trial failure last month of Torisel, after that kidney cancer drug was unable to demonstrate it was more effective than Roche's Avastin plus interferon alfa-2b.