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FDA report questions efficacy of Pfizer's kidney cancer drug Inlyta

Report comes ahead of advisory committee meeting to review the pharma company's marketing application for Inlyta

A report for the US Food and Drug Administration (FDA) has questioned the benefits of Pfizer's kidney cancer drug Inlyta (axitinib).

Written by regulatory reviewers, the report comes ahead of an advisory committee meeting to review Pfizer's marketing application for the drug.

Inlyta is due for review by the FDA's Oncologic Drugs Advisory Committee (ODAC) on December 7 as a second-line treatment for patients with advanced renal cell carcinoma, based on the results of a single efficacy study in 723 patients which compared Pfizer's drug to Bayer's Nexavar (sorafenib).

The reviewers are concerned that most of the benefit seen in the study in terms of progression-free survival was driven by a subset of patients treated with prior cytokine therapy, which is not commonly used in the US. Rather, most US patients are treated with Pfizer's own Sutent (sunitinib).

Overall, patients on Inlyta had a median progression-free survival of 6.7 months compared to 4.7 months for Nexavar, according to the study. Looking at a smaller subset of Sutent-treated patients however, the reviewers conclude that the survival benefit was 1.4 months, according to their report.

"ODAC advice is sought on whether the issue of the PFS benefit being driven by a subset of patients that is likely to be scarce in the United States and the more meagre progression-free survival benefit in patients previously treated with sunitinib would affect the overall benefit:risk assessment," they write.

Renal cell carcinoma is the most prevalent form of kidney cancer, and five-year survival rates remain low at around 20 per cent despite a swathe of new drugs entering the market in recent years. Sutent had sales of $298m for Pfizer in the third-quarter, while Nexavar pulled in €177m ($237m) for Bayer. Both are approved for other cancer indications beyond renal cell carcinoma.

Earlier this year, analysts at Morningstar predicted that Inlyta could achieve peak sales of $1bn or more if approved.

Pfizer submitted the drug for approval in the EU in June as a second-line treatment for renal cell carcinoma, and it is also in phase III testing in treatment-naive patients. Meanwhile, a phase II trial is ongoing in a form of liver cancer (hepatocellular carcinoma).

The FDA is scheduled to deliver a verdict on the Inlyta application on March 13, 2012.

6th December 2011

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