Allos Cancer Drug Homers at FDA Panel
Updated to reflect Allos' next-day stock price
WESTMINSTER, Colo. (TheStreet) -- Baseball analogies were tossed around frequently during Wednesday's federal advisory panel meeting convened to debate the clinical benefit of Allos Therapeutics'(ALTH Quote) lymphoma drug Folotyn. One panel member said the drug wasn't a home run, more like a base hit -- a single at best. Another cancer expert said Folotyn, if playing in the big leagues, would struggle to hit above the Mendoza line. But while the debate over Folotyn's merits was intense at time, the Food and Drug Administration's advisory panel decided overwhelmingly, by a 10-4 vote, to recommend the drug's approval as a treatment for patients with advanced peripheral T-cell lymphoma (PTCL) -- a rare but aggressive cancer of the immune system. To use a baseball analogy of my own, Folotyn's critics Wednesday, most notably the University of Washington biostatistician Dr. Tom Fleming, played a good game but ended up like the Red Sox's Bill Buckner while Allos used a Mookie Wilson base hit to nail down the victory. But like the Mets of 1986, Allos needs another win for the title. That hopefully comes Sept. 24 when the FDA is expected to announce its final approval decision. I believe the FDA will approve Folotyn in three weeks, based on the data, discussions and outcome of Wednesday's advisory panel meeting. Not that being an Allos bull was all that easy Wednesday. Drama was in abundance as the company's representatives battled the FDA and some experts on the panel over the central question of whether or not PTCL patients derived clinical benefit from treatment with Folotyn.- Loading Comments...
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