said late Wednesday that its experimental cancer drug Bexxar has suffered another setback on the road to approval.
The drug will not will be on the agenda of a Food and Drug Administration advisory panel meeting slated for February, as expected. Corixa said that while the FDA continues to work on its review of Bexxar, the agency still has a lot of work to do and is not ready for the drug to be discussed by the panel.
This is the second time that Bexxar has failed to make the agenda of the Oncologic Drugs Advisory Committee. Last October, Corixa tried, but failed, to get the drug discussed at the December meeting.
The next ODAC meeting is scheduled for early June, but Corixa doesn't know yet whether it will make thispanel either, it said today.
Shares of Corixa closed Wednesday down 6 cents to$14.77 per share. The stock then fell another 78cents, or 5%, to $13.99 in after-hours trading.
Corixa is desperate to get Bexxar reviewed andapproved because it's locked in a competitive battlewith
and its rival drug Zevalin,which has already received a thumbs up from the ODAC panel. Monday, however, Idec warned that final approval of Zevalin was being delayed by the FDA until the company can sort out manufacturing issues.
Rumors of another delay in Bexxar made the rounds of the JPMorgan H&Q conference Tuesday. The negativechatter was certainly encouraged -- and spread -- byIdec executives, who were holding one-on-one meetingswith fund managers at the conference.
But now that Corixa has confirmed the rumors ofanother delay, Wall Street fears are rising that theFDA could ask the company to conduct another clinicaltrial -- more talk making its way around the JPMorganconference.
Corixa spokesman Jim DeNike said the company believesthat the additional information already supplied toregulators should be enough to answer all theirquestions, and that no clinical trials for Bexxarshould be needed.
"There is nothing out there that would substantiatethat rumor," said DeNike.
Both Bexxar and Zevalin are a new type of cancerfighter -- monoclonal antibodies with an extra kick ofradiation attached, which increases their tumor-killingpower. If approved, both drugs will be used inpatients suffering from advanced cases of non-Hodgkinslymphoma.