The fast track designation for Nexavar (sorafenib) tablets in advanced (including locally unresectable and metastatic) melanoma means Bayer and Onyx will be able to file a new drug application (NDA) for the drug 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 commencing the review process. There may also be the possibility of a priority review, which could decrease the typical review period.
An approval in this melanoma indication would add to the drug’s existing FDA approval in advanced renal cell carcinoma, which was granted in December 2005.
A phase III trial, named PRISM, is currently underway, evaluating Nexavar administered in combination with a standard dosing schedule (21-day cycles) of carboplatin (AUC 6) and paclitaxel (225mg/m2). The study is designed to measure the safety and efficacy of Nexavar when co-administered with chemotherapy, and has progression-free survival as its primary endpoint.
In addition, a phase III trial sponsored by the Eastern Cooperative Oncology Group (ECOG) is also underway. The trial will evaluate carboplatin and paclitaxel with or without the administration of Nexavar in patients with unresectable stage III or stage IV melanoma, and has overall survival as its primary endpoint.