HealthDay News — The FDA has expanded approval for the anti-cancer drug sorafenib (Nexavar, Bayer HealthCare and Onyx Pharmaceuticals) to include late-stage differentiated thyroid cancer, the most common type of thyroid cancer.
Thyroid cancer will be diagnosed in an estimated 60,220 Americans in 2013, and an estimated 1,850 will die from the disease, according to the FDA.
“Physicians now have an approved treatment option that may help improve care in this patient population,” Marcia Brose, MD, PhD, of the Abramson Cancer Center and Perelman School of Medicine at the University of Pennsylvania, said in a press release.
Sorafenib is now indicated for patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment. The approval for this new use is based on clinical studies involving 417 people whose thyroid cancer did not respond to treatment. Patients were randomly assigned to receive sorafenib 400 mg orally twice daily or matching placebo (1:1).
Sorafenib increased the time recipients lived without cancer progression by about 41% compared to those who took a placebo, as assessed by blinded independent radiological review. Median progression free survival was 10.8 and 5.8 months for the sorafenib and placebo arms, respectively (HR 0.59; 95% CI: 0.46, 0.76; P<0.001). The overall response rates were 12% versus 1% for sorafenib and placebo, respectively.
The most common side effects included diarrhea, fatigue, infection, hair loss, skin reactions, weight loss, loss of appetite, abdominal pain and hypertension. The agency also warned that increased production of thyroid stimulating hormone — a potential promoter of thyroid cancer — was possible among the drug’s users.
Sorafenib first received FDA-approval to treat advanced kidney cancer in 2005, followed by approval to treat advanced liver cancer in 2007, the agency said.