The fast track designation will allow Bayer and Onyx 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 commencing the review process. Gaining a priority review for Nexavar (sorafenib) in metastatic hepatocellular carcinoma (HCC) could also be possible.
“We are pleased that Nexavar has received fast track designation by the FDA for this difficult-to-treat patient population, and we look forward to submitting our phase III data when the analyses are complete,” said Dr Susan Kelley, vice president of oncology at Bayer Pharmaceuticals.
A phase III trial of Nexavar administered as a single agent to patients with advanced liver cancer is currently underway, having recently completed patient enrollment. The study is designed to measure differences in overall survival, time-to-symptom progression and time-to-tumor progression of Nexavar versus placebo.
A randomized phase II trial for liver cancer patients to evaluate the efficacy of Nexavar in combination with the chemotherapeutic agent doxorubicin is also currently open and recruiting patients.