BioCentury
ARTICLE | Clinical News

Nexavar sorafenib regulatory update

May 12, 2014 7:00 AM UTC

EMA's CHMP issued a positive opinion recommending expanding the label for Nexavar sorafenib to include treatment of progressive, locally advanced or metastatic, differentiated thyroid cancer in patients who no longer respond to treatment with radioactive iodine. Bayer expects a decision from the European Commission mid-year. Nexavar is already approved more than 100 countries. In the EU, it is approved to treat hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC) in patients who have failed prior interferon alpha- or IL-2-based therapy or are considered unsuitable for such therapy. ...