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FDA panel backs Pfizer's Inlyta for kidney cancer

Unanimous recommendation from oncology panel for VEGF inhibitor despite previous reservations

A US Food and Drug Administration (FDA) advisory panel gave its support to Pfizer's VEGF inhibitor Inlyta as a treatment for advanced kidney cancer yesterday, voting unanimously to recommend approval of the product.

The Oncologic Drugs Advisory Committee (ODAC) voted 13 to 0 that Inlyta (axitinib) had a favourable benefit/risk profile as a treatment for patients with advanced renal cell carcinoma who had failed first-line therapy.

The FDA will deliver a final verdict on the marketing application in 2012 and, if approved, analysts have suggested it could achieve sales of $500m within the next three years and $1bn at peak.

The positive verdict came despite earlier reservations by FDA reviewers about the benefits of Inlyta in this setting.

A document released for consideration at the ODAC meeting pointed out that most of the progression-free survival benefit seen in the study was driven by a subpopulation of patients treated first-line with cytokines. Cytokine therapy is not commonly used in the US, where most newly-diagnosed patients receive Pfizer's Sutent (sunitinib).

Overall, patients on Inlyta had a median progression-free survival of 6.7 months compared to 4.7 months for comparator drug, Bayer's Nexavar (sorafenib), but this benefit was trimmed to 1.7 months if cytokine-treated patients were excluded. There was no difference between the groups in terms of overall survival.

Panellists acknowledged the FDA's concerns about subset analysis, but concluded that Pfizer had done enough in the trial to warrant approval of the product as a "useful alternative" to approved therapies for RCC, according to Wyndham Wilson of the National Cancer Institute, who served as the ODAC chair.

Inlyta could be a good option for patients who cannot tolerate other VEGF inhibitors, as it appears to have a different spectrum of side effects than Nexavar and Sutent.

Dr Mace Rothenberg, senior vice president of clinical development and medical affairs at Pfizer's oncology business unit, said: "We look forward to continued discussions with the FDA as we take the next steps in the regulatory process for axitinib."

8th December 2011


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