Public HealthPfizer's Sutent Is Recommended For Reimbursement For Gastrointestinal Stromal Tumor Patients By British Health Agency
Pfizer Inc said that the United Kingdom"s National Institute for Health and Clinical Excellence (NICE) has issued its final appraisal document (FAD) recommending reimbursement for Sutent (sunitinib malate) as a second-line treatment for patients with advanced gastrointestinal stromal tumor (GIST). This recommendation follows NICE"s recently published guidance recommending reimbursement for Sutent for the first-line treatment of advanced kidney cancer.
The guidance states that Sutent is recommended for reimbursement as a treatment option for patients with advanced GIST after disease progression on or intolerance to imatinib mesylate, and who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.* According to NICE, "the benefits seen in time to tumor progression and progression free survival were such that a substantial improvement in overall survival with sunitinib treatment was probable."
"NICE"s decision gives hope to patients with GIST who develop resistance to imatinib," said Dr. Mace Rothenberg, senior vice president, clinical development and medical affairs, Pfizer"s Oncology Business Unit. "Insights into the causative pathways involved with cancers like GIST will help us bring Sutent to the right patient at the right time."
NICE"s decision was based on data from a pivotal Phase 3 trial of Sutent compared with placebo in patients with advanced GIST. Sutent increased time to tumor progression in the study by almost five months (6.4 weeks vs. 27.3 weeks, P About Advanced Gastrointestinal Stromal Tumor
Gastrointestinal stromal tumor (GIST) is found in the gastrointestinal (GI) tract and belongs to a group of rare cancers called soft tissue sarcomas. Sarcomas begin in muscle, fat, fibrous tissue, blood vessels, or other supporting tissue of the body. Advanced GIST affects approximately 90 to 150 people in the U.K. each year, with an annual worldwide incidence of approximately 1.5 cases per 100,000 persons.
Important SUTENT® (sunitinib malate) Safety Information
Women of child bearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on SUTENT.
Decreases in left ventricular ejection fraction (LVEF) to below the lower limit of normal (LLN) have been observed. Patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure.
Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. CBCs with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.
The most common adverse reactions in clinical trials were fatigue, asthenia, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspensia, abdominal pain, constipation, hypertension, rash, hand-foot syndrome, skin discoloration, altered taste, anorexia and bleeding.
For more information on SUTENT and Pfizer Oncology, including full prescribing information for SUTENT (sunitinib malate), please visit http://www.pfizer.com.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options for cancer patients worldwide. Our robust pipeline consists of 21 biologics and small molecules in clinical development across four scientific platforms - anti-angiogenesis, signal transduction, immuno-oncology, and cytotoxic potentiators. Pfizer Oncology has over 200 clinical trials including robust Phase 3 clinical trial programs in renal cell carcinoma, prostate cancer, non-small cell lung cancer, metastatic breast cancer, colorectal cancer, and hepatocellular carcinoma.
By working collaboratively with academic institutions, researchers, governments, and licensing partners, Pfizer Oncology strives to transform treatment by targeting the right drug for the right patient at the right time. For more information please visit http://www.pfizer.com.
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*Patients without symptoms or only mildly symptomatic from their cancer.
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