FDA Advisory Committee Recommends Accelerated Approval For Allos Therapeutics’ FOLOTYN

Allos Therapeutics has announced that FDA’s Oncologic Drugs Advisory Committee (ODAC) voted that the response rate and duration of response observed with FOLOTYNTM (pralatrexate) are likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). If approved, FOLOTYN would be the first drug approved by the FDA for the treatment of relapsed or refractory PTCL.

The ODAC recommendation was based on results from PROPEL, a pivotal phase 2 international trial that evaluated FOLTYN for the treatment of patients with relapsed or refractory PTCL. The PROPEL trial was conducted under an agreement reached with the FDA under its special protocol assessment (SPA process).

The FDA is expected to make a decision whether to approve the company’s New Drug Application (NDA) for FOLOTYN by September 24, 2009.

Paul Berns, chief executive officer at Allos Therapeutics, said: “We are very pleased that the advisory committee today voted to recommend accelerated approval of the FOLOTYN NDA. We believe FOLOTYN has the potential to offer an important new treatment option for patients with relapsed or refractory PTCL, an indication for which there are currently no FDA-approved therapies and no accepted standard of care. We will continue to work with FDA to bring FOLOTYN to the US market as soon as possible so that patients can benefit from this potential new treatment option.”