Pfizer Sutent Label Expansion May Hinge On Disease-Free Survival Stats

Conflict of interest waivers for US FDA advisory committee review of sunitinib's supplemental application signal that difference in statistical analyses for disease-free survival could be key area of discussion.

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Is Sutent's future cloudy?

When the Sept. 19 Oncologic Drugs Advisory Committee (ODAC) review of Pfizer Inc.'s Sutent (sunitinib) was announced for the adjuvant treatment of patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy, it raised a red flag.

The US FDA's decision to take the application to committee was surprising – Sutent has an established history in RCC, even approved as first-line therapy – and worrisome – supplemental

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