The FDA has granted Fast Track designation to Viventia Biotech for Proxinium, a drug for the treatment of patients with recurrent squamous cell carcinoma of the head and neck (SCCHN). Viventia was previously designated an orphan drug in the US and EU and will begin phase II trials in the US and Canada this year. Each year 55,000 new cases of SCCHN occur in the US with 14,000 deaths annually.
- see this press release for more