Pfizer has announced that a supplemental New Drug Application (sNDA) for Sutent (sunitinib) has been accepted for filing by the US Food and Drug Administration (FDA). If approved, the sNDA would expand the approved use of Sutent to include use as an adjuvant treatment in adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancer-containing kidney). In addition, the European Medicines Agency (EMA) has validated for review a Type II Variation application for Sutent in the same patient population. Sutent is the most widely prescribed first-line treatment for advanced RCC worldwide.

The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2018.

“There is currently no approved therapy for patients with kidney cancer post-surgery, and we know that some patients are at risk of their cancer returning,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “Given our experience with Sutent in patients with advanced or metastatic kidney cancer, we set out to determine whether Sutent could reduce the risk of recurrence in high-risk patients.”

The submissions are based on results from the S-TRAC trial, a randomized double-blind Phase 3 trial of adjuvant SUTENT vs. placebo in 615 patients with locoregional, resected RCC at high risk of recurrence. The study met its primary endpoint of improving disease-free survival (DFS), and the results were published online by the New England Journal of Medicine in October 2016. The S-TRAC trial has two cohorts: Global and China. These results are from the Global cohort only. Results from the China cohort are not yet mature and will be reported at a later date.

In the trial, after up to one year of treatment, the median DFS in participants treated with Sutent after surgery was 6.8 years compared with 5.6 years for patients treated with placebo as assessed by blinded independent central review. Patients treated with Sutent experienced an overall reduction in risk of recurrence or death of 24 percent. This difference was statistically significant. In addition, in a secondary subgroup analysis of patients at higher risk than the overall study population, the median DFS with Sutent was 6.2 years compared with 4.0 years for patients treated with placebo as assessed by blinded independent central review. Higher risk was defined as those with a stage 3 tumor, no or undetermined nodal involvement, no metastasis, Fuhrman grade 2 or higher, and an Eastern Cooperative Oncology Group (ECOG) score, of 1 or higher, or a stage 4 tumor, or any tumor with nodal involvement.

The adverse events seen in the trial were consistent with the known safety profile of SUTENT. The most common adverse reactions (>20%) were diarrhea, painful palms and soles (palmar-plantar erythrodysaesthesia (PPE); also known as Hand-Foot Syndrome), hypertension, and fatigue. Grade =3 adverse events were more frequent with Sutent (62.1%) vs. placebo (21.1%). No deaths occurred due to treatment.

As a leader in the treatment of advanced RCC, Pfizer is dedicated to meeting the unmet needs of these patients and advancing the science of RCC through research into established and novel compounds. Our near term areas of focus include expanding access of our marketed projects, exploration of biomarkers to better personalize therapy and immunotherapy combinations.