Priority review is granted by the FDA for a treatment that addresses an unmet medical need and demonstrates an improvement over existing therapies. The FDA expedites the approval process for applications granted priority review from ten to six months.
The supplemental new drug application (sNDA) submitted to the FDA for this indication included data from the Phase III VISTA study, a large, well-controlled international clinical trial, comparing a Velcade based regimen to a traditional standard of care.
Nancy Simonian, chief medical officer of Millennium, said: “Priority review designation puts us on track for a potential label expansion decision by June 20, 2008. The rapid action by the FDA puts us one step closer to establishing Velcade based therapies as a standard of care for patients with newly diagnosed multiple myeloma.”