European orphan status granted to Bayer and Onyx drug

This designation is based on a recommendation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA).

“This orphan medicinal product designation demonstrates the European Commission’s commitment to the study and development of treatments for rare diseases,” said Dr Susan Kelley, vice president of oncology at Bayer Pharmaceuticals. “This support adds momentum to our research efforts with Nexavar and brings hope of a new treatment option to liver cancer patients in Europe.”

At the 16th American Association for Cancer Research meeting in 2004, investigators reported that, in a phase II single agent study, 43% of patients treated with Nexavar experienced stable disease for at least four months and an additional 9% of patients experienced tumor shrinkage.

A phase III trial of Nexavar administered as a single agent is ongoing. The study is designed to measure differences in overall survival, time-to- symptom progression and time-to-tumor progression (TTP) of Nexavar versus placebo in liver cancer patients. A randomized phase II trial for liver cancer patients to evaluate the efficacy of Nexavar in combination with the chemotherapeutic agent doxorubicin is also ongoing.