FDA Approves New Indication for GLIADEL® Wafer
BALTIMORE, MD, Feb. 26, 2003 -
Guilford Pharmaceuticals, Inc. (Nasdaq: GLFD) announced today that
the company's marketed product, GLIADEL Wafer (polife- prosan 20 with
carmustine implant), has received approval from the United States
Food and Drug Administration (FDA) for use in newly diagnosed patients
with high-grade, malignant glioma as an adjunct to surgery and radiation.
"I believe these findings will prompt
many physicians to incorporate this therapy at the time of initial
surgery"
"This action by FDA brings new hope to seriously ill patients with brain cancer," commented Henry Friedman, M.D., the James B. Powell, Jr. Professor of Neuro-
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Oncology, and Co-Director of The
Brain Tumor Center at Duke University. “ The clinical results
with GLIADEL Wafer at the
“The benefits of GLIADEL® Wafer will now be available to a broader number of patients.”
time of initial surgery are clinically meaningful
and statistically significant. I believe these findings will prompt
many physicians to incorporate this therapy at the time of initial
surgery. Along with radiotherapy and systemic chemotherapy, GLIADEL
Wafer's use at the time of initial surgery forms the basis of a four pronged attack on malignant brain cancer."
"Guilford is proud of its commitment to develop new, innovative therapies,
such as GLIADEL Wafer, that have a significant impact on the lives
of patients," commented Craig R. Smith, M.D., Chairman and Chief Executive
Officer. With an expanded label indication that provides for administration
of GLIADEL Wafer at the time of initial surgery, followed by radiation,
the benefits of GLIADEL Wafer will now be available to a broader number
of patients."
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