Pfizer’s Inlyta gains European recommendation
pharmafile | May 28, 2012 | News story | Sales and Marketing | Inlyta. axitinib, Sutent, renal cell carcinoma
Pfizer’s kidney cancer pill Inlyta has been recommended for use by a European committee.
The Committee for Medicinal Products for Human Use (CHMP) is recommending Inlyta (axitinib) for patients with renal cell carcinoma after the failure of treatment with Pfizer’s Sutent or a cytokine.
But the Committee said that a pharmacovigilance plan for Inlyta would be implemented as part of the marketing authorisation.
The final decision on whether to recommend the drug rests with the European Commission, which usually takes three months to come to a conclusion.
Mace Rothenberg, senior VP of clinical development and medical affairs for Pfizer’s Oncology Business Unit, said: “Pfizer is very pleased that the CHMP has adopted a positive opinion for axitinib as a second-line treatment for advanced renal cell carcinoma, and we look forward to the decision of the European Commission.
“Despite recent advances in the treatment of advanced kidney cancer, there is a clear need for additional treatment options for patients whose disease has progressed following first-line medications.”
The drug, which comes in pill form, is a multi kinase inhibitor that targets VEGF receptors 1, 2 and 3 and gained FDA approval in January.
Last year it outperformed Bayer’s RCC drug Nexavar (sorafenib) in a Phase III head-to-head trial and produced a median progression free survival of 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).
These treatments 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 – they estimate peak annual sales of around $600 million.
Inlyta is also 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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