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This afternoon, the FDA announced that the ODAC committee had voted 10-4 this afternoon in favour of Allos Therapeutics Folotyn (pralatrexate) for the treatment of refractory PTCL, a rare form of NHL that attacks the immune system.  Allos have posted a statement on the topic; it's good to see small companies responding and providing prompt information on the day of the news:

"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, or SPA, process.  The SPA process allows for FDA
evaluation of a clinical trial protocol intended to form the primary
basis of an efficacy claim in support of an NDA, and provides an
agreement that the trial design, including trial size, clinical
endpoints and data analyses are acceptable to the FDA."

A final decision is due by the FDA on September 24th, so it looks like a launch is imminent, unless they decide not to follow their panel's advice.  The ODAC news is not surprising after the encouraging data presented by the company on pralatrexate at recent ASH and ASCO meetings.

The Allos shares were suspended today pending the decision, but given the positive opinion the trend tomorrow will most likely be up.  You can track it here.

It's been quite a wild ride over the last two days with two ODAC rejections
yesterday in AML for Genzyme and Vion followed by two positive opinions in NHL
today and we haven't even discussed the news of Pfizer's big fine for marketing practices.  That's a story for another day…

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