Oncologic Drugs Committee Split on Risk-Benefit Profile of Pfizer Candidate

September 21, 2017

An FDA advisory committee deadlocked 6 to 6 on whether the benefits of a Pfizer drug treatment for recurrent renal cell carcinoma outweighed the risks.

The Oncologic Drugs Advisory Committee was considering Pfizer’s sNDA for Sutent, a drug with a proposed indication for adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. A final FDA decision on whether to approve the sNDA is expected by January 2018.

FDA representatives noted the drug was associated with more toxicities than the placebo in clinical trials, but they also flagged the high unmet medical need and lack of approved therapies for renal cell carcinoma.

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