The B-cell follicular non-Hodgkin’s lymphoma (NHL) treatment is Favrille’s lead product candidate for this disease. The drug is currently in a pivotal phase III clinical trial following Rituxan therapy (produced by Genentech) in patients with follicular B-cell NHL.
“This decision by the FDA has the potential to save us valuable time in the regulatory approval process, and also serves as an important acknowledgement of the potential for FavId in the treatment of B-cell follicular NHL,” said Dr John Longenecker, president and CEO of Favrille.
A fast track designation means that FDA will expedite the development and review of the product.
Favrille is nearing completion of patient enrollment in its phase III registration trial with a target of 342 eligible patients. Favrille anticipates an analysis of a secondary endpoint of the trial, response improvement, during the fourth quarter of this year. The final analysis of the primary endpoint of the trial, time to disease progression, is expected during the second half of 2007.