Breaking News
May 24, 2018 - CU research sheds light on liver disease caused by intravenous nutrition
May 24, 2018 - Skin cream containing rapamycin reduces TSC-related facial tumors
May 24, 2018 - Suicide rates twice as high among black children finds new study
May 24, 2018 - Researchers find new method to treat severe asthma
May 24, 2018 - Scientists report new strategy for fighting bacteria
May 24, 2018 - South Asians living in the United States more likely to die of heart disease and stroke
May 24, 2018 - Health Tip: Why Get a Biopsy
May 24, 2018 - Metabolic Syndrome Prevalence by Race/Ethnicity and Sex in the United States, National Health and Nutrition Examination Survey, 1988–2012
May 24, 2018 - Motivation to move may start with being mindful
May 24, 2018 - Advanced genetics study of TB bacteria uncovers virulent ‘Beijing lineage’ strain among young adults
May 24, 2018 - Friends tend to have similar pain tolerance levels, study reveals
May 24, 2018 - Now more of us can count on more time dodging the dementia bullet
May 24, 2018 - Global healthcare access and quality improved from 2000-2016
May 24, 2018 - Virtual follow-up visits for hypertension care just as effective as in-person office visits
May 24, 2018 - New research reveals links between type 1 diabetes and mental health
May 24, 2018 - Antioxidant-enriched multivitamin may decrease respiratory illnesses in CF patients, finds study
May 24, 2018 - Antidepressant treatments increase risk of weight gain, study finds
May 24, 2018 - INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray
May 24, 2018 - Poor older adults with Medicaid insurance more likely to die after hospital discharge
May 24, 2018 - Early-life obesity linked to children’s lower perceptual reasoning and working memory scores
May 24, 2018 - Health and diagnostics to soon be digitalized with advent of AI
May 24, 2018 - USC researchers develop new portable device for early-stage malaria detection
May 24, 2018 - Psychologists show that depression accelerates brain aging
May 24, 2018 - Novel IR imaging offers rapid and reliable analysis of cancer tissues
May 24, 2018 - Tau mutations may serve as novel risk factor for cancer
May 24, 2018 - Sun Pharma Announces FDA Approval of Yonsa (abiraterone acetate) to Treat Metastatic Castration-Resistant Prostate Cancer
May 24, 2018 - Nurse dead in Congo as Ebola vaccination campaign starts
May 24, 2018 - Unique imaging technique identifies biomarkers of cellular damage done by diabetic retinopathy
May 24, 2018 - Study identifies key food allergy policies that parents want in schools to improve safety of kids
May 24, 2018 - Formaldehyde risk found to be higher in e-cigarettes than originally thought
May 24, 2018 - NIH commences first-in-human trial evaluating experimental treatment for Ebola
May 24, 2018 - Study finds no link between surveillance intensity and detection of recurrence or survival in CRC patients
May 24, 2018 - FDA Alert: Oral Over-the-Counter Benzocaine Products: Drug Safety Communication
May 24, 2018 - Fiber-fermenting bacteria improve health of type 2 diabetes patients
May 24, 2018 - Free e-cigarettes do not help smokers quit, money does finds study
May 24, 2018 - Higher exposure to carbon monoxide in utero increases risk of poor lung function in infants
May 24, 2018 - Neurologists identify new type of vertigo
May 24, 2018 - Scientists identify new inherited neurodevelopmental disease
May 24, 2018 - New family support program improves patient-centered care and lowers hospitalization costs
May 24, 2018 - Researchers take important step toward finding protein biomarkers during cancer surgery
May 24, 2018 - Deadly form of black lung disease found to be increasing among U.S. coal miners
May 24, 2018 - Robust Immune Responses for Herpes Zoster Subunit Vaccine
May 24, 2018 - Optical Coherence Tomography | Texas Heart Institute
May 24, 2018 - Type 2 diabetes slowly rising in Auckland kids – Pacific and Māori have highest rates
May 24, 2018 - Study explores brain chemistry of alcohol exposure in people with family history of AUD
May 24, 2018 - Study shows AVATS procedure as safe, effective alternative for patients deemed ‘inoperable’
May 24, 2018 - Comparative Analysis of a Complex Monoclonal Antibody
May 24, 2018 - Penn investigators discover source of immune molecule involved in nasal polyps, asthma
May 24, 2018 - Berries and Grapes May Keep You Breathin’ Easy
May 24, 2018 - Access and utilization of dental services for Medicaid children 2013-2015
May 23, 2018 - New research raises concern about rate of postpartum hemorrhage
May 23, 2018 - Researchers create new modeling framework that takes a zoonotic perspective on Ebola
May 23, 2018 - Study compares bacteria in humans to the laboratory
May 23, 2018 - Frequent sauna bathing reduces risk of stroke
May 23, 2018 - Landmark trial to test implantable defibrillator in diabetic patients with history of heart attack
May 23, 2018 - Vitamin C consumption may reduce harm to baby’s lungs due to smoking during pregnancy
May 23, 2018 - Researchers complete genomic map of chronic lymphocytic leukemia
May 23, 2018 - Medical students take to the streets to learn about real world problems at the root of poor health
May 23, 2018 - New efforts to curb high blood pressure in Asia
May 23, 2018 - Malaria-causing parasite seeks refuge inside the liver to replicate and survive
May 23, 2018 - Slower rates of stimulation may be more effective in brain therapy, suggests research
May 23, 2018 - Study finds connection between one partner’s BMI and other spouse’s risk of developing diabetes
May 23, 2018 - Mapping the Genes Responsible for Pluripotency
May 23, 2018 - FDA Alert: Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall
May 23, 2018 - Genetic fixer-uppers may predict bladder cancer prognosis
May 23, 2018 - Investigational technology could increase donor organ supply for lung transplants
May 23, 2018 - Prediabetic patients with OSA could lower their resting heart rates by using CPAP
May 23, 2018 - Schizophrenics’ blood samples feature genetic material from more types of microorganisms
May 23, 2018 - Subtle hearing deficits can change the brains of young people
May 23, 2018 - New study shows increased rates of hospitalization for suicide among youths
May 23, 2018 - Proportion of Drug-Intoxicated Organ Donors on the Rise in U.S.
May 23, 2018 - Using virtual biopsies to improve melanoma detection
May 23, 2018 - Compassion meditation training may increase brain’s resilience to suffering of other people
May 23, 2018 - New AAD PSA uses social media imagery to highlight tanning hazards
May 23, 2018 - Frequent MRSA surveillance could contain infection in newborns, study finds
May 23, 2018 - Medicaid expansion linked to reduction in ICU utilization
May 23, 2018 - Proteins moderating nicotine dependence may help fat cells burn energy
May 23, 2018 - Researchers identify mechanisms that regulate mammary gland development
May 23, 2018 - ‘Low-Alcohol’ Booze Labels May Backfire
May 23, 2018 - Social isolation could increase risk of death, hospitalizations for heart failure patients
FDA Approves Sutent (sunitinib malate) for Adjuvant Treatment of Adult Patients at High Risk of Recurrent Renal Cell Carcinoma

FDA Approves Sutent (sunitinib malate) for Adjuvant Treatment of Adult Patients at High Risk of Recurrent Renal Cell Carcinoma

image_pdfDownload PDFimage_print

November 16, 2017 — The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy). Adjuvant treatment is a form of therapy that is taken after an initial surgical removal to lower the risk of the cancer coming back.

“This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with this disease who have a nephrectomy are often at high risk of the cancer returning,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “There is now an approved therapy for patients who previously did not have options to potentially reduce cancer recurrence.”

The National Cancer Institute (NCI) at the National Institutes of Health estimates approximately 63,990 patients will be diagnosed with kidney and renal cell pelvis cancer this year, and 14,440 will die of the disease.

Sutent is a kinase inhibitor that works by blocking several enzymes that promote cell growth. Sutent was first approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma. It is also approved for patients with a certain type of pancreatic cancer.

The approval of Sutent for the adjuvant treatment of renal cell carcinoma was based on a randomized trial of 615 patients with high risk of recurrent renal cell carcinoma following nephrectomy. The study measured the amount of time after the start of the trial that it took for the cancer to come back, for the patient to develop another unrelated cancer, or for death to occur from any cause (disease-free survival). After five years, 59.3 percent of patients treated with Sutent had not experienced cancer recurrence or death compared with 51.3 percent of patients receiving placebo.

Common side effects of Sutent include fatigue, diarrhea, inflammation of the mucous membranes and inside the mouth (mucositis/stomatitis), nausea, decreased appetite/anorexia, vomiting, abdominal pain, skin reactions on the hands and feet (hand-foot syndrome), high blood pressure (hypertension), bleeding events, altered taste (dysgeusia), indigestion (dyspepsia) and low levels of blood platelets (thrombocytopenia).

Severe side effects of Sutent include severe liver damage (hepatotoxicity), heart failure (low left ventricular ejection fraction), heart attack (myocardial ischemia/infarction), abnormal health rhythm (prolonged QT intervals/Torsade de Pointes), hypertension, bleeding (hemorrhagic events), metabolic abnormalities due to breakdown of the tumor (tumor lysis syndrome), blood vessel abnormalities leading to blood clots in the small blood vessels resulting in low platelet counts and organ dysfunction (thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome), high levels of protein in the urine (proteinuria), thyroid dysfunction, low blood sugar (hypoglycemia), breakdown of the bone of the jaw due to loss of blood supply (osteonecrosis), and wound healing complications. Patients should stop taking Sutent if serious skin reactions occur (necrotizing fasciitis, erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis). Women who are pregnant should not take Sutent because it may cause harm to a developing fetus.

The labeling for Sutent contains a boxed warning to alert healthcare professionals and patients about the risk of severe liver damage (hepatoxicity), which may result in liver failure or death.

The FDA granted the approval of Sutent to Pfizer Inc.

Source: FDA

Posted: November 2017

Related Articles:

Sutent (sunitinib malate) FDA Approval History

Tagged with:

About author

Related Articles