Applications seek to expand approved use of SUTENT based on data from the Phase 3 S-TRAC trial
NEW YORK, NY, USA I May 31, 2017 I Pfizer Inc. (NYSE:PFE) today announced that a supplemental New Drug Application (sNDA) for SUTENT® (sunitinib) has been accepted for filing by the U.S. 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.
About Renal Cell Carcinoma (RCC)
Each year, approximately 338,000 new cases of kidney cancer are diagnosed worldwide, representing approximately 2-3 percent of all cancers.1 Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for around 90 percent of cases.2 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.3 Of those patients, some are considered at high risk for the cancer to return after surgical removal.4 These patients are considered candidates for adjuvant therapy.
About SUTENT® (sunitinib malate)
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.
SUTENT is indicated for the treatment of advanced renal cell carcinoma (RCC), gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. SUTENT is not approved in the adjuvant setting.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on those living with cancer. As a leader in oncology speeding cures and accessible breakthrough medicines to patients, Pfizer Oncology is helping to redefine life with cancer. Our strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines. Because Pfizer Oncology knows that success in oncology is not measured solely by the medicines you manufacture, but rather by the meaningful partnerships you make to have a more positive impact on people’s lives.
Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
SOURCE: Pfizer
Post Views: 76
Applications seek to expand approved use of SUTENT based on data from the Phase 3 S-TRAC trial
NEW YORK, NY, USA I May 31, 2017 I Pfizer Inc. (NYSE:PFE) today announced that a supplemental New Drug Application (sNDA) for SUTENT® (sunitinib) has been accepted for filing by the U.S. 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.
About Renal Cell Carcinoma (RCC)
Each year, approximately 338,000 new cases of kidney cancer are diagnosed worldwide, representing approximately 2-3 percent of all cancers.1 Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for around 90 percent of cases.2 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.3 Of those patients, some are considered at high risk for the cancer to return after surgical removal.4 These patients are considered candidates for adjuvant therapy.
About SUTENT® (sunitinib malate)
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.
SUTENT is indicated for the treatment of advanced renal cell carcinoma (RCC), gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. SUTENT is not approved in the adjuvant setting.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on those living with cancer. As a leader in oncology speeding cures and accessible breakthrough medicines to patients, Pfizer Oncology is helping to redefine life with cancer. Our strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines. Because Pfizer Oncology knows that success in oncology is not measured solely by the medicines you manufacture, but rather by the meaningful partnerships you make to have a more positive impact on people’s lives.
Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
SOURCE: Pfizer
Post Views: 76
