Designed to extend survival in patients with late-stage disease
THURSDAY, April 7 (HealthDay News) -- Vandetanib has been approved by the U.S. Food and Drug Administration as the first drug to treat a rare form of thyroid cancer in its latter stages.
Medullary thyroid cancer accounts for 3 percent to 5 percent of the estimated 44,600 cases of thyroid cancer diagnosed each year in the United States, the FDA said in a news release. Typical symptoms include coughing, difficultly swallowing, thyroid enlargement, neck swelling, a lump on the thyroid and voice changes. Medullary thyroid cancer may occur spontaneously or be related to a genetic syndrome.
Vandetanib was evaluated in a study of 331 people with late-stage medullary thyroid cancer. Average progression-free survival among those who took the drug was 22.6 months, compared to 16.4 months among those who took an inactive placebo, the agency said.
Five people treated with the drug died from causes that included respiratory problems, heart failure and a bacterial blood infection called sepsis. Vandetanib also was shown to affect the electrical activity of the heart, which could result in life-threatening irregular heartbeat, the FDA said.
The most common side effects reported were diarrhea, rash, nausea, high blood pressure, headache, fatigue, loss of appetite and abdominal pain.
Vandetanib is produced by AstraZeneca Pharmaceuticals, based in Wilmington, Del.
To learn more about medullary thyroid cancer, visit the U.S. National Cancer Institute.
-- Scott Roberts
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