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发表于 2009-9-3 05:45 AM
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SILVER SPRING, Md., Sept 2 (Reuters) - Clinical data for Allos Therapeutics
Inc's experimental lymphoma drug Folotyn were not overwhelming but did look
promising for a certain group of patients, a U.S. medical advisory panel said on
Wednesday in backing the product.
The Food and Drug Administration's panel of outside experts, in a 10-4
vote, said the company's results were strong enough to show patients with an
aggressive type of the cancer were likely to benefit.
"This drug is not a home run. It's a base hit. It's not even a double --
it's a single," said panelist Dr. Brad Kahl, a professor at the University of
Wisconsin who still backed the drug.
It was enough of a benefit for most panelists, who expressed concern for
the small number of previously treated patients with peripheral T-cell lymphoma
(PTCL) who have relapsed and have no other options.
The company is expecting the FDA to make its decision by Sept. 24,
although the agency has missed several such deadlines in recent months. The FDA
will weigh the panel's recommendation before making its final approval decision.
"This was an important step forward," Allos' President and Chief
Executive Officer Paul Berns told reporters after the meeting.
PTCL is a less common type of non-Hodgkin's lymphoma, but it can be more
aggressive than its B-cell counterpart and affects about 9,500 people in the
United States, according to the FDA.
It also accounts for about 10 to 15 percent of the 66,000 new U.S. cases
of non-Hodgkin's lymphoma expected to be diagnosed this year, the company also
said, citing American Cancer Society data.
The drug aims to camouflage itself as a folic acid so it can be absorbed
by the tumor, then attack the cancer.
But FDA officials cautioned the panel that while the drug seems to have
some active effect on PTCL, that effect alone is not enough to merit approval.
The agency is weighing Folotyn under an expedited review process in which
products must be shown to be better than other treatments. For fuller approval,
"we need additional studies here," said Dr. Richard Pazdur, director of the
FDA's Office of Oncology Drug Products.
Pazdur and other FDA staff noted that just 27 percent of the trial's 115
patients responded to Folotyn, most only partially. Slightly more than half of
those who saw some of benefit responded for less than 14 weeks, they added.
Most panel members said they were conflicted about approval, but company
officials won them over by pointing to patients' unmet medical needs. Allos is
also studying Folotyn as possible therapy for other cancers, including non-small
cell lung cancer and bladder cancer.
"It's a miserable disease with really no good alternative," said panelist
Dr. Michael Link, chief of oncology at Stanford University's School of Medicine,
who backed Folotyn.
Still, among the four panelists who rejected the drug, concerns remained
about how much of an effect it would have given the limited data.
Panelist Dr. Ronald Richardson of the Mayo Clinic said that the number of
patients who responded was not "particularly robust" and that he was
"underwhelmed" by how long the drug's effect lasted. |
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发表于 2009-9-3 04:20 AM
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