Nexavar Approval Expanded for Common Thyroid Cancer11/22/13
FRIDAY, Nov. 22, 2013 (HealthDay News) -- U.S. Food and Drug
Administration approval for the anti-cancer drug Nexavar
(sorafenib) has been expanded to include late-stage differentiated
thyroid cancer, the most common type of thyroid cancer.
In a Friday news release about the approval, the agency said
thyroid cancer will be diagnosed in an estimated 60,220 Americans
this year, and an estimated 1,850 will die from the disease.
Nexavar is designed to inhibit proteins that prompt cancer cells
to divide and grow. The new approval is meant for people with
differentiated thyroid cancer that no longer responds to
radioactive iodine treatment.
The drug was approved for this new use based on clinical studies
involving 417 people whose thyroid cancer did not respond to
treatment. The drug increased the time recipients lived without
cancer progression by about 41 percent compared to those who took a
placebo, the FDA said.
The most common side effects of Nexavar included diarrhea,
fatigue, infection, hair loss, skin reactions, weight loss, loss of
appetite, abdominal pain and high blood pressure. The agency also
warned that increased production of thyroid stimulating hormone --
a potential promoter of thyroid cancer -- was possible among the
Nexavar was FDA-approved to treat advanced kidney cancer in
2005, followed by approval to treat advanced liver cancer in 2007,
the agency said.
The drug is marketed by Bayer HealthCare Pharmaceuticals, based
in Wayne, N.J.
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