NEXAVAR GETS FAST-TRACK DESIGNATION FOR HCC INDICATION
Bayer Pharmaceuticals and Onyx Pharmaceuticals have announced that Nexavar (sorafenib) tablets have been granted fast-track designation by the FDA for the treatment of metastatic hepatocellular carcinoma (HCC), or liver cancer. Nexavar was approved by the FDA in December 2005 for the treatment of patients with advanced renal cell carcinoma (RCC).
Fast-track designation allows the company to file a new drug application (NDA) on a rolling basis as data become available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to beginning the review process.