FDA Panel Recommends Folotyn, Wants New Romidepsin Study

The Oncologic Drugs Advisory Committee has voted 10–4 to recommend approval of Allos Therapeutics’ Folotyn in patients with relapsed or refractory peripheral T-cell lymphoma. The panel found Folotyn (pralatrexate) has a response rate and duration of response likely to predict clinical benefit, although some panel members were unconvinced.
Washington Drug Letter