Breaking News
December 15, 2017 - For marketplace customers who delay, auto-enrollment could be nasty wake-up
December 15, 2017 - Researchers identify potential alternatives to tackle drug resistant malaria parasites
December 15, 2017 - Scientists unravel mystery of how immune cells remember infections decades later
December 15, 2017 - Outcomes Poorer for Black Patients with Early Breast Ca
December 15, 2017 - Liposuction May Ease Limb Swelling in Cancer Patients
December 15, 2017 - How well can digital assistants answer questions on sex?
December 15, 2017 - NIH-funded study to explore hearing loss risk in Detroit firefighters
December 15, 2017 - Caris Life Sciences reveals identification of new mechanism of action to treat NHL
December 15, 2017 - Loyola Medicine study finds high success rate for diabetic Charcot foot surgery
December 15, 2017 - Bone marrow edema does not increase due to intense physical activity, study finds
December 15, 2017 - Human ‘common cold’ virus kills healthy chimpanzees in Uganda
December 15, 2017 - Experience of reflex walking refines perception of biological motion during early infancy
December 15, 2017 - FDA Approves Admelog (insulin lispro) Rapid-Acting “Follow-On” Insulin Product to Treat Diabetes
December 14, 2017 - Friday Feedback: Good Idea for Ex-Pharma Exec to Run HHS?
December 14, 2017 - More than 200 people sickened onboard Ovation of Seas cruise
December 14, 2017 - FDA announces new approach for sharing updates on antibiotics, antifungal drugs to physicians
December 14, 2017 - Steroid study provides new insights into medicines’ side effects
December 14, 2017 - Government announces plans to include eye test reminder during driving license renewal
December 14, 2017 - Non-ionizing radiation from magnetic fields could have adverse biological impacts on health
December 14, 2017 - Bi-annual MRI beats mammograms in detecting breast cancer among women with genetic risk
December 14, 2017 - Researchers develop new method for quickly detecting signs of multiple sclerosis
December 14, 2017 - In era of increased competition, hospitals fret over ratings
December 14, 2017 - Female veterans experience improvement in low back pain with course of chiropractic care
December 14, 2017 - Relieving Symptoms of Cystic Fibrosis with Exercise
December 14, 2017 - FDA Alert: Blue Pearl All Natural Male Enhancement Supplement: Recall
December 14, 2017 - CardioBrief: In Defense Of ORBITA
December 14, 2017 - Definition of High Blood Pressure Drops: MedlinePlus Health News
December 14, 2017 - Drug may help surgical patients stop opioids sooner
December 14, 2017 - Researchers develop biosensor that enables development of new health tests
December 14, 2017 - Radiation therapy can be used to treat patients with life-threatening heart rhythm
December 14, 2017 - UVA researchers developing tool to help prostate cancer patients weigh treatment options
December 14, 2017 - Experts tell Congress how to cut drug prices
December 14, 2017 - Researchers use cryptographic techniques to decode activity of motor neurons
December 14, 2017 - Study finds changes in the heart after spinal cord injury
December 14, 2017 - Health Highlights: Dec. 12, 2017
December 14, 2017 - Pelzman’s Picks: How States Can Cut Disparities in Care and Costs
December 14, 2017 - New Hemophilia Treatment Stems Bleeding Episodes: MedlinePlus Health News
December 14, 2017 - Onetime ‘world’s heaviest man’ has second surgery in Mexico
December 14, 2017 - Belgian researchers create transplantable artificial ovary prototype
December 14, 2017 - Using atraumatic needles for lumbar punctures decreases risk of complications
December 14, 2017 - Outpatient total knee replacement surgery linked to higher rates of complications
December 14, 2017 - Social impairments can be corrected by brain stimulation
December 14, 2017 - Studies reveal possibility for memory T cells to serve a dual purpose
December 14, 2017 - Antibody-Drug Conjugate Ups PFS in Untreated Hodgkin’s
December 14, 2017 - Study finds reading information aloud to yourself improves memory
December 14, 2017 - Researchers use RNA nanotechnology to program exosomes for delivering effective cancer therapies
December 14, 2017 - Living Lyme disease bacteria found months after antibiotic treatment
December 14, 2017 - These annual checkups help seniors not only survive but thrive
December 14, 2017 - Study reveals impact of diabetes during pregnancy on baby’s heart
December 14, 2017 - Hydraulic fracturing is harmful to infants health, study states
December 14, 2017 - Huntington’s disease drug clears initial hurdles
December 14, 2017 - TPU researchers create 3D-printed models of children’s hearts
December 14, 2017 - Brain responses of children with inherited dyslexia risk predict their future reading speed
December 14, 2017 - People diagnosed with schizophrenia or bipolar disorder may actually have treatable condition
December 14, 2017 - Study: New Furosemide Formulation Simplifies Administration for HF
December 14, 2017 - Discrimination harms your health—and your partner’s
December 14, 2017 - Having older brothers may increase the likelihood of being gay
December 14, 2017 - New scientific yardstick released to help early detection of Alzheimer’s disease
December 14, 2017 - New finding demonstrates what happens at cellular level during onset of type2 diabetes
December 14, 2017 - Study identifies potassium as key to circadian rhythms in red blood cells
December 14, 2017 - Good friends might be your best brain booster as you age
December 14, 2017 - NIH expected to award up to $70 million to launch Alzheimer’s Clinical Trials Consortium
December 14, 2017 - Pitting pathogens against each other could prevent drug resistance emerging
December 14, 2017 - Study provides new insights into development of Sonic Hedgehog medulloblastoma
December 14, 2017 - Dr. Reddy’s Announces Approval of Impoyz (clobetasol propionate) Cream for Plaque Psoriasis
December 14, 2017 - Gene Screens Can Alter Perception, Behavior
December 14, 2017 - Can Scrotal Vein Condition Hike Heart Risks?: MedlinePlus Health News
December 14, 2017 - Molecules in spit may be able to diagnose and predict length of concussions
December 14, 2017 - Children’s Colorado and RxRevu partner to help prescribers better meet needs of pediatric patients
December 14, 2017 - Researchers discover new way to attack drug-resistant prostate cancer cells
December 14, 2017 - Scientists develop new, high resolution method for identifying microbial species and strains
December 14, 2017 - Declining trend of salmonellosis cases has leveled off in the EU
December 14, 2017 - Death receptors in the blood can help measure risk of cardiovascular diseases, type 2 diabetes
December 14, 2017 - How to Perk Up the Holidays for Hospital Patients
December 14, 2017 - Prolonged Sedation May be Bad for Baby’s Brain
December 14, 2017 - The pediatric submersion score predicts children at low risk for injury following submersions
December 14, 2017 - Video game helps doctors to quickly recognize trauma patients who need high levels of care
December 14, 2017 - Younger persons newly-diagnosed with type 2 diabetes have poorer health than older patients
December 14, 2017 - Clinician re-examines evidence on re-use of catheters and UTIs in people with spinal cord injuries
December 14, 2017 - UK and Russian researchers join forces against AMR
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