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Phase 3 Trial of Sunitinib in Breast Cancer Discontinued
“We are disappointed with these results given the previous findings that suggested sunitinib may provide benefit for patients with this difficult-to-treat cancer,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “In ongoing studies, we remain committed to evaluating sunitinib in advanced breast cancer and are continuing to study sunitinib in different populations and with different regimens.”
Pfizer has notified clinical trial investigators involved in the study and regulatory agencies of these findings. The Company encourages investigators to determine the best course of action for their individual patients.
The company is continuing to evaluate sunitinib as a single-agent and in combination with standard-of-care chemotherapy in specific patient populations with advanced breast cancer through three additional Phase 3 and two Phase 2 trials.
Sunitinib is currently approved for both gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced / metastatic renal cell carcinoma (RCC) based on efficacy and safety data from large, randomized Phase 3 clinical trials. Sunitinib has played an important role in reshaping the treatment landscape for these two difficult-to-treat cancers. To date, more than 58,000 patients globally have been treated with sunitinib in the clinical setting and in clinical trials.
About Sutent (sunitinib malate)
Sutent is an oral multi-kinase inhibitor approved for the treatment of GIST after disease progression on or intolerance to imatinib mesylate and advanced / metastatic RCC.
Sutent 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: Pfizer, Inc.