Bayer says that its investigational anti-cancer agent, BAY 43-9006, met its primary endpoint of significantly delaying disease progression in a Phase III trial in patients with advanced kidney cancer, versus placebo. The German company says that, as a result of these data, it is planning to prepare a New Drug Application together with biotechnology partner Onyx Pharmaceuticals, for possible accelerated approval in the US.
The study was launched back in 2003 and enrolled over 800 advanced kidney cancer patients [[28/10/03g]]. As well as assessing improvement in overall survival, the trial also looked at time to disease progression, overall response rate, safety, quality of life and the product’s pharmacokinetics. The two firms say they intend to submit the Phase III data for the upcoming American Society of Clinical Oncology meeting in Orlando, Florida, in May.
Last year, the US Food and Drug Administration awarded the product fast track and orphan drug status, which would speed up the approval process and entitle it to up to seven years marketing exclusivity should it ultimately win the green light in the world’s largest pharmaceutical market [[07/04/04e]], [[28/10/04f]].
BAY 43-9006 is seen as one of the keys to Bayer’s future performance, and the firm is hoping to ultimately launch the drug next year. It is also being investigated as a treatment for advanced liver cancer, with late-stage skin cancer trials set to being shortly [[15/03/05c]].