FDA
16th November 2017

Split Decision from FDA Advisory Committee on Approval for Sutent® In Patients at High Risk of Recurrent Renal Cell Carcinoma After Surgery

On September 19th the Oncologic Advisory Committee (ODAC) discussed supplemental new drug application (sNDA 021938/033) for SUTENT® (sunitinib malate) oral capsules, submitted by C.P.

Split Decision from FDA Advisory Committee on Approval for Sutent® In Patients at High Risk of Recurrent Renal Cell Carcinoma After Surgery

On September 19th the Oncologic Advisory Committee (ODAC) discussed supplemental new drug application (sNDA 021938/033) for SUTENT® (sunitinib malate) oral capsules, submitted by C.P. Pharmaceuticals International C.V., and represented by authorized US agent, Pfizer, Inc. The proposed indication for this product is as an adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy. Sutent was first approved in the US in 2006 for first-line treatment of advanced RCC.

The committee was asked to vote on the benefit-risk profile of Sutent based on findings from the phase III S-TRAC trial. S-TRAC was a randomized double-blind trial of adjuvant Sutent vs. placebo in 615 patients with high-risk RCC. Adjuvant Sutent prolonged disease-free survival (DFS) by 1.2 years, after nephrectomy, when compared with placebo.

The committee was split on the benefit-risk profile, voting 6 Yes to 6 No on the potential approval of Sutent for use as an adjuvant therapy in patients with RCC who have received nephrectomy and are at high risk of recurrence. Members who voted “Yes” relayed that the side effects of Sutent are manageable since they can be discussed between the patient and physician. In addition, it was commented that S-TRAC was a large, well conducted study that showed benefit in DFS in a specific high -risk patient population, and that the study addressed an area of unmet need. The members who voted “No” believed that while the study was well designed, an improvement in overall survival was not demonstrated and there is substantial toxicity with one year of adjuvant Sutent.

The role of ODAC is to provide recommendations to the FDA, in which the agency will then take into consideration when determining its final approval decision.  The FDA decision is expected by January 2018.

ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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