Regulatory Affairs

Pfizer announces outcome of FDA's ODAC meeting for SUTENT in patients at high risk of recurrent renal cell carcinoma after surgery

Published 20 September 2017

Pfizer announced that the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).

The role of the Advisory Committee is to provide recommendations to the FDA. The ODAC discussions were based on the supplemental New Drug Application (sNDA) currently under review by the FDA. The FDA decision on whether or not to approve the sNDA is anticipated by January 2018.

Approximately 75 percent of patients with clear cell RCC are non-metastatic, and 70-80 percent will have a nephrectomy with curative intent, or surgical removal of the tumor.1 High-risk patients represent approximately 15 percent of all patients with primary resected RCC and approximately 60 percent of these high-risk patients will have recurrence and develop metastatic disease within five years.2 The current treatment is surgery followed by observation. This treatment is suboptimal for patients at high risk of recurrence.

“We are encouraged by today’s productive discussion and look forward to working with the FDA over the next few weeks as they incorporate today’s discussion into their review and decision regarding SUTENT in this patient population,” said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development.

“SUTENT has long been a standard of care for the treatment of advanced RCC and we believe that this potential benefit can be extended into patients with high-risk of RCC recurrence, as demonstrated in the S-TRAC trial.”

The sNDA under review by the FDA is 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 by The New England Journal of Medicine in October 2016.

SUTENT was first approved in the United States in 2006 for the treatment of advanced RCC, where it is the most widely prescribed first-line treatment. Now approved in 119 countries,3 more than 350,000 patients have been treated with SUTENT in its approved indications of advanced RCC, imatinib-resistant or -intolerant gastrointestinal stromal tumors (GIST) and advanced pancreatic neuroendocrine tumors (pNET).4 Use of SUTENT is not approved in the adjuvant setting.

SUTENT is supported by an extensive body of evidence in scientific literature, including more than 440 publications.

The ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes recommendations to the FDA. Its vote is not binding, but is considered by the FDA in its decision making process.

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 products, exploration of biomarkers to better personalize therapy and immunotherapy combinations.

SUTENT is an oral multi-kinase inhibitor that works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer.

Two important SUTENT targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENT also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.

Source: Company Press Release