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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID
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To: HARRY GIBSON who wrote (1150)7/25/1997 12:29:00 PM
From: Henry Niman   of 1762
 
FDA panel backs IDEC's Rituximab

BETHESDA, July 25 (Reuter) - A U.S. Food and Drug
Administration advisory panel on Friday unanimously voted that
IDEC Pharmaceutical Corp's IDPH.O Rituxan (Rituximab) is
effective and safe for treating non-Hodgkins lymphoma.
IDEC sought FDA approval for Rituximab, which will be
co-promoted with Genentech Inc GNE.N, in February 1997.
If approved by FDA, Rituximab will be the first-ever
monoclonal therapeutic for cancer.
"This is an agent we should add to our armamentarium," said
panel chairwoman Virginia Broudy of the University of
Washington's School of Medicine.
Rituximab is meant for patients who have not responded to
previous therapy for low-grade or follicular B-cell
non-Hodgkin's lymphoma (NHL), which affect two-thirds of the
240,000 Americans with NHL.
This type of NHL is characterized by a series of remissions
and relapses, with treatment becoming less effective with each
succeeding illness, IDEC's Antonio Grillo-Lopez said.
Rituximab, tested in late-stage NHL patients, gave a
response rate -- 48 percent -- comparable to chemotherapy or
other NHL therapies, and with a better safety profile,
Grillo-Lopez said.
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