Folotyn gets accelerated approval

FDA granted accelerated approval to an NDA for Folotyn pralatrexate from Allos Therapeutics Inc. (NASDAQ:ALTH) to treat relapsed or refractory peripheral T cell lymphoma (PTCL). As part of the approval, Allos will conduct additional studies to confirm that tumor shrinkage predicts that patients will live longer. Earlier this month, FDA's Oncologic Drugs Advisory Committee recommended accelerated approval of the small molecule dihydrofolate reductase (DHFR) inhibitor (See BioCentury, Sep. 07, 2009). ...