FDA Committee Recommends Approval of QLT's PHOTOFRIN(R) For Palliative
Treatment of Late-Stage Lung Cancer
WASHINGTON, D.C., Sept. 3 /CNW-PRN/ - The Oncologic Drugs Advisory Committee
(ODAC) of the U.S. Food and Drug Administration recommended unanimously (eight
to zero) today that the FDA expand its approval of QLT PhotoTherapeutics
Inc.'s PHOTOFRIN(R) (porfimer sodium) for Injection to include palliation of
late-stage lung cancer.
Specifically, the committee voted in favor of approving PHOTOFRIN for the
reduction of obstruction and palliation of symptoms in patients with
completely or partially obstructing endobronchial nonsmall cell lung cancer.
The recommendation will now be considered by the FDA as it completes its
review of the revised supplemental New Drug Application (NDA) submitted by QLT
in early 1998. The FDA's decision is expected no later than March 1999.
Pending regulatory approval, a U.S. commercial launch by Sanofi
Pharmaceuticals, Inc.--QLT's U.S. marketing and distribution partner--is
expected to follow shortly thereafter.
We're very pleased with the committee's recommendation. It takes QLT one step
closer to offering PHOTOFRIN as an alternative palliative therapy for patients
with advanced lung cancer,'' said Dr. Julia Levy, QLT's President and CEO.
``After such a long and rigorous review process, today's recommendation is a
real accomplishment for the team of talented scientific, clinical and
regulatory professionals--led by Alexandra Mancini, our Vice President of
Regulatory Affairs--who were involved in this submission.
The continued expansion of the PHOTOFRIN label, combined with the development
of QLT's second product, verteporfin, as a treatment for age-related macular
degeneration (AMD), solidifies our position as a global leader in the field of
PHOTOFRIN was previously approved by the FDA in January 1998 as a potentially-
curative treatment for early-stage micro-invasive lung cancer in patients who
are not candidates for surgery or radiotherapy, and in 1995 as a palliative
treatment for certain patients with esophageal cancer.
The supplemental NDA was submitted as a four-part application for a drug-
device combination consisting of QLT's PHOTOFRIN(R) and OPTIGUIDE cylindrical
diffusers as well as laser systems manufactured by Coherent Medical Group and
QLT PhotoTherapeutics Inc. is a world leader in the development and
commercialization of proprietary pharmaceutical products for use in
photodynamic therapy, an emerging field of medicine utilizing light-activated
drugs in the treatment of disease. QLT's innovative science has advanced
photodynamic therapy beyond applications in cancer towards potential
breakthrough treatments in ophthalmology and autoimmune disease.
QLT's portfolio of products include PHOTOFRIN(R) (porfimer sodium), the
world's only approved photodynamic therapy drug, used in the treatment of
various cancers throughout North America, Japan and Europe; and verteporfin
(BPD-MA), a therapy in final stages of testing to treat age-related macular
degeneration (AMD), the leading cause of blindness among the elderly.
QLT PhotoTherapeutics Inc. is listed on The Nasdaq Stock Market under the
trading symbol ``QLTIF'' and on The Toronto Stock Exchange under the trading
The foregoing information contains forward-looking statements which involve
known and unknown risks, uncertainties and other factors which may cause the
actual results to be materially different from any future results,
performance, or achievements expressed or implied by such statements. Such
factors include: risks associated with the commercialization of PHOTOFRIN(R)
and verteporfin (BPD-MA); uncertainties relating to product development; the
Company's history of operating losses and uncertainty of future profitability;
uncertainty of access to additional capital; rapid technological change and
competition; uncertainty regarding patents and proprietary rights; product
liability claims and insurance; manufacturing uncertainties; anti-takeover
provisions; uncertainty of pricing and reimbursement; no assurance of
regulatory approval; government regulation; and dependence on corporate
relationships; among others, all as described in the Company's Annual
Information Form on Form 10-K.
SOURCE: QLT PhotoTherapeutics Inc.
CO: QLT PhotoTherapeutics Inc.
ST: British Columbia
09/03/98 14:32 EDT http://www.prnewswire.com
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