The US Food and Drug Administration (FDA) has extended the approval of Pfizer’s drug Sutent (sunitinib malate) as an adjuvant treatment for adults at a high risk of experiencing a return of renal cell carcinoma following the removal of a kidney.
Adjuvant therapies are treatments following an initial surgical removal of a tumor to lower the risk of cancer returning. Approval of Sutent as an adjuvant therapy was granted following a randomized trial of 615 patients with a high risk of recurrent renal cell carcinoma following a nephrectomy (kidney removal). After five years, 59 percent of patients treated with Sutent had not died or experienced a reappearance of cancer, compared with just 51 percent of patients who were given a placebo.
Daniel George, MD, study investigator and medical oncologist at Duke University Medical Center, stated: “This adjuvant therapy is the first-of-its-kind and a remarkable clinical development for these patients who before today, have been restricted to a wait and see approach.”
Each year, around 60,000 people in the United States develop kidney and renal pelvic cancers, leading to the deaths of around 13,000 people, according to the Centers for Disease Control and Prevention (CDC). Common symptoms of kidney cancer include a lump or mass in the kidney or abdomen area, blood in the ring, pain in the side or lower back, fatigue, recurrent fever, loss of appetite, weight loss, blocked bowels, and a general feeling of ill health.
Potential treatments for renal cell carcinoma include surgery to remove the kidney, radiation therapy, chemotherapy, biologics and other drugs to inhibit the action and growth of the cancerous cells. Sutent falls into the final category, blocking an enzyme and preventing tumors from developing their own blood vessels. This slows cancer growth and the spread of cancer to other cells by cutting the tumor off from nutrients and oxygen. Other medications used to treat renal cell carcinoma are tyrosine kinase inhibitors Votrient (pazopanib) and Inlyta (axitinib), and chemotherapy drugs such as Afinitor (everolimus).
What is Sutent?
Sutent was first approved in 2006 for treating certain patients with gastrointestinal stroll tumors, pancreatic cancer, and advanced renal cell carcinoma. The kinase inhibitor blocks the action of a number of enzymes responsible for promoting cell growth. The latest approval of the drug enables physicians to prescribe the medication as an adjuvant treatment for kidney cancer.
Common Side Effects of Sutent
Common side effects of Sutent include diarrhea, inflammation of mucous membranes, nausea, decreased appetite, abdominal pain, skin reactions on the hands and feet, hypertension, dysgeusia (altered taste), dyspepsia (indigestion) and low platelet levels.
Severe side effects have also been experienced by some patients, including severe liver damage, heart failure, heart attack, abnormal heart rhythm, hypertension, bleeding, metabolic abnormalities due to tumor breakdown, blood vessel abnormalities, high protein levels in urine and thyroid dysfunction. For a full list of side effects and more information on Sutent, visit https://www.sutent.com.
