Pfizer has got a green light in Europe to sell Sutent, its new oncology product, to treat advanced kidney cancer, setting up a head-to-head battle in the marketplace with rival product Nexavar from Bayer and Onyx Pharmaceuticals, which was cleared by the European Medicines Agency earlier this month.

The EMEA has cleared Sutent (sunitinib) for renal cell carcinoma and a rare form of stomach cancer called gastrointestinal stromal tumour (GIST), although Pfizer said both are conditional and would be firmed up only if Phase III results, due to be submitted next month, stand up to scrutiny.

Similar to Nexavar (sorafenib), Sutent has been cleared for second-line use in renal cell carcinoma patients who have failed prior treatment with interferon alfa and/or interleukin-2, with Nexavar also approved for use in patients deemed unsuitable for first-line treatment. Both drugs were approved in the USA last December.

Both of these orally-active drugs have been tipped as potential blockbusters in kidney cancer, because current treatment tends to have serious side effects and has to be delivered by injection.

Sutent's approval in GIST is also second-line, after failure of initial treatment with Novartis’ Glivec/Gleevec (imatinib), and follows US clearance for this indication in January. Despite its second-line labelling, Sutent is expected to have an immediate impact on treatment because many patients develop resistance to Gleevec within 18 months of treatment.

For Pfizer the drug also marks its first major foray into the cancer sector, although it had ramped up R&D in this area and now has two other compounds in Phase III trials, including CP-675,206 for melanoma (partnered with Abgenix) and PF-3512676 for non-small cell lung cancer.