Nexavar® (sorafenib) FDA-approved for Differentiated Thyroid Cancer
The US Food and Drug Administration (FDA) announced approval of sorafenib (Nexavar® tablets, Bayer Healthcare Pharmaceuticals Inc., Wayne, NJ) for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine (RAI) treatment. Sorafenib was previously approved to treat hepatocellular carcinoma and advanced renal cell carcinoma.
The safety and effectiveness of sorafenib was established in a multicenter, randomized, double-blind, placebo-controlled clinical study involving 417 patients with locally recurrent or metastatic, progressive DTC refractory to RAI treatment. Progression-free survival was the primary efficacy outcome measure determined by a blinded independent radiological review. Other efficacy outcome measures included overall survival, tumor response rate, and duration of response.
- Sorafenib increased the length of time patients lived without cancer progressing by 41%
- Fifty percent of patients receiving sorafenib lived without cancer progression for at least 10.8 months compared to at least 5.8 months for participants who received ap placebo
Patients were randomized to receive sorafenib 400 mg twice daily (n=207) or placebo (n=210). Forty-eight percent of the patients were male, median age was 63 years, 62% had an Eastern Cooperative Oncology Group performance status of 0, and 99% had undergone thyroidectomy.
The most common side effects in patients treated with sorafenib were alopecia, decreased appetite, diarrhea, fatigue, gastrointestinal and abdominal pain, hand-foot skin reaction, hypertension, infection, nausea, rash, and weight loss.
November 25, 2013