Here is another one:
9/18/97 FDA Panel Partially Clears QLT's Light-Activated Lung
Cancer Dr
BETHESDA, Md. -(Dow Jones)- A Food and Drug Administration panel
Thursday recommended expanded approval of QLT PhotoTherapeutics
Inc.'s drug Photofrin for treating some lung cancer patients,
but stopped short of approving the light-activated drug for all
the uses the company had requested.
Photofrin, approved in the U.S. last year to treat esophageal
cancer, is seen as a potentially powerful new treatment option.
Company officials appeared before the FDA's Oncologic Drugs
Advisory Panel Thursday to make their case for approval for
multiple uses.
Specifically, the company wanted the panel to approve the
drug as a palliative, to treat non-small-cell cancer in
late-stage patients who can't undergo surgery or undergo
radiation therapy -- to relieve symptoms without trying to cure
them of disease.
The company also wanted the drug approved for use in treating
in situ cases - very rare, very early stages in which the
disease is localized, without disturbing or invading surrounding
tissue.
Panel members, however, voted against the use of Photofrin in
palliation, arguing there simply isn't enough data to approve
such a use. The committee also voted against the use of the drug
for in situ cases, saying the company didn't present data to
prove the in situ patients actually had cancer.
Nearly every member of the committee said the data presented
by the company was flawed. Despite their reservations, they
voted their approval.
"This is an elegant technique. It makes sense that if you
open up obstruction that patients should be improved. I'm
prepared to accept that that is the case - I just don't know if
that happens 50% of the time, 30% of the time or 15% of the
time," said Dr. Richard L. Schilsky, director of the University
of Chicago Cancer Research Center.
Photofrin is unique in that it works by light activation.
After infusion into the body, the drug is absorbed by cancerous
cells. A physician then uses fiber optics and a laser to shine a
light on the affected tissue. The light causes Photofrin to
activate and react with oxygen, causing a local inflammatory
action that destroys the affected tissue.
This procedure selectively targets the cells to be treated
and causes less trauma than surgery or chemotherapy. Because
normal cells don't absorb the drug, there is no damage to the
tissue surrounding the tumors.
Analysts with Dillon Read & Co. believe that the additional
indication may increase QLT's royalties from Photofrin to $26.5
million by 2000. QLT took in under $1 million from royalties of
the product last year.
Photofrin is sold in the U.S. by Sanofi-Winthrop SA, which
has recently implemented new marketing programs that have helped
spur increased sales.
QLT doesn't manufacture the laser used with Photofrin.
However, two laser companies, Coherent Inc. and Laserscope Inc.,
have conducted clinical trials with Photofrin and have applied
to the FDA for approval to use their lasers with the drug.
Trading in both QLT and Laserscope was halted Thursday ahead
of the panel's decision and didn't resume trading.
Last month, Laserscope received a conditional approval for
its laser and will receive full marketing approval provided the
agency approves Photofrin for the treatment of lung cancer.
Traditionally, lung cancer has been one of the most difficult
types of cancer to treat. Although there is a one-year survival
rate of 41%, only 13% of patients manage to survive five years
after diagnosis.
In clinical trials in Japan, Photofrin caused an immediate
complete tumor response in 90.6% of lung cancer patients. These
results were also long lasting, with 62.5% of patients remaining
tumor-free after five years.
Likewise, clinical trials conducted in France showed that 88%
of patients with inoperable early-stage lung cancer had a
complete tumor response after treatment with Photofrin.
In other clinical trials, Photofrin was better than treatment
with laser alone in causing a reduction in tumor size, lessening
of symptoms and time to progression of the disease.
Separately, the physicians who led the trials estimated that
treatment with Photofrin is 40% less costly than traditional
surgery because of a significantly shorter recuperation time as
well as less time needed to perform the surgery.
Lung cancer is responsible for approximately 160,000 deaths
annually in the U.S., or 27% of all cancer deaths. It is the
single-largest cause of death among all cancers in the U.S.
Copyright (c) 1997 Dow Jones & Company, Inc.
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