FDA Has Several Issues With Allos Data For Folotyn
28 Agosto 2009 - 2:27PM
Dow Jones News
U.S. Food and Drug Administration medical reviewers on Friday
said they have several issues with data Allos Therapeutics Inc.
(ALTH) submitted to support getting FDA approval for its proposed
lymphoma drug Folotyn.
FDA scientists said they can't precisely determine how Folotyn
affected some of the patients studied because of inconsistencies in
how the patients were evaluated.
Allos is seeking FDA approval to offer Folotyn to patients with
an aggressive type of non-Hodgkin's lymphoma, a common blood
cancer. Specifically, the company wants to market the product to
people with peripheral T-cell lymphoma. About 9,500 people get
diagnosed with the disease annually in the U.S.
An FDA-sponsored panel of medical experts will review the
product next week.
In briefing documents on its Web site, the FDA asked the panel
to advise it on whether Folotyn's benefits outweigh the risks.
Allos enrolled more than 100 patients with lymphoma into a
clinical trial. Allos evaluated patients' tumors size and status by
doing imaging scans every 14 weeks.
Twenty-nine, or 27%, of the patients enrolled had their tumor
growth affected by the drug. However, the FDA noted reviewers on an
independent committee that Allos had evaluate the scans didn't
agree on how well the patients responded to Folotyn.
The FDA said that because of the long time between scans and the
disagreement among the team that reviewed the scans, it wants the
panel's advice on the significance of the data Allos submitted.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com