Thema: Presse: FDA approves new indication for Gliadel® Wafer
Presse: FDA approves new indication for Gliadel® Wafer
Dirk[a]
27.02.2003 08:06:27
FDA Approves New Indication for GLIADEL® Wafer
BALTIMORE, MD, Feb. 26, 2003 -
Guilford Pharmaceuticals, Inc. 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-
Oncology, and Co-Director of The Brain Tumor Center at Duke University. " The clinical results with GLIADEL Wafer at the 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."
"The benefits of GLIADEL® Wafer will now be available to a broader number of patients."
"Guilford is proud of its commitment to develop new, innovative therapies, such as GLIADEL(R) Wafer, that have a significant impact on the lives of patients," commented Craig R. Smith, M.D., Chairman and Chief Executive Officer. "Each year in the United States there are approximately 11,000 surgeries performed to treat malignant brain cancer. Prior to this approval, only those patients who suffered recurrence of glioblastoma multiforme and required a second surgery could benefit from treatment with GLIADEL(R) Wafer. With an expanded label indication that provides for administration of GLIADEL(R) Wafer at the time of initial surgery, followed by radiation, the benefits of GLIADEL(R) Wafer will now be available to a broader number of patients."
"We intend to initiate a new product launch in the United States to raise awareness among neurosurgeons, neuro-oncologists and patients of the benefits associated with GLIADEL(R) Wafer during initial surgery," Dr. Smith continued. "Over the coming weeks, we also intend to resubmit our European regulatory application for GLIADEL(R) Wafer seeking approval for use in initial surgery in Europe so that we can offer the benefits of GLIADEL(R) Wafer to an even larger population."
Clinical Program Background
A Phase III double blind, placebo-controlled clinical study of GLIADEL(R) Wafer was conducted at 38 centers in 14 countries. A total of 240 adult men and women undergoing initial surgical resection of a high-grade malignant glioma were enrolled and randomly assigned to receive implantation of either GLIADEL(R) Wafers or placebo wafers into the resection cavity followed about two weeks later by radiation therapy. The primary end-point for the trial was survival.
Long-Term Survival Results
Complete follow up for as long as 48 months was obtained for 239 of the 240 patients. Of the 11 patients known to be alive on the date of last follow up, 9 received GLIADEL(R) Wafer and 2 received placebo. Survival was prolonged in the GLIADEL(R) Wafer treatment group (median survival increased to 13.9 months from 11.6 months, p<0.05). The overall risk of dying during 3-4 years after treatment was reduced in the GLIADEL(R) Wafer treatment group, as reflected by a hazard ratio of 0.73 (95% CI: 0.56-0.95; p<0.05).
Safety Information
Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL(R) Wafer should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL(R) Wafer, including one case leading to brain herniation. GLIADEL(R) Wafer contains carmustine and should not be given to patients who are allergic to carmustine. Carmustine can also cause fetal harm when administered to a pregnant woman.
About GLIADEL(R) Wafer
GLIADEL(R) Wafer is the only marketed cancer treatment capable of delivering chemotherapy directly to the site of a brain cancer, bypassing the blood-brain barrier and minimizing drug exposure to other areas of the body. GLIADEL(R) Wafer is a small, white to off-white dime-sized wafer comprised of a biodegradable polymer (polifeprosan 20) incorporating 7.7 mg. of carmustine (BCNU), a chemotherapeutic agent usually administered intravenously to treat a malignant glioma. Up to eight GLIADEL(R) Wafers can be implanted in the cavity created when a surgeon removes a brain tumor. There, they slowly dissolve, releasing BCNU directly to the tumor site in high concentrations, while minimizing drug exposure to other areas of the body.
BALTIMORE, MD, Feb. 26, 2003 -
Guilford Pharmaceuticals, Inc. 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-
Oncology, and Co-Director of The Brain Tumor Center at Duke University. " The clinical results with GLIADEL Wafer at the 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."
"The benefits of GLIADEL® Wafer will now be available to a broader number of patients."
"Guilford is proud of its commitment to develop new, innovative therapies, such as GLIADEL(R) Wafer, that have a significant impact on the lives of patients," commented Craig R. Smith, M.D., Chairman and Chief Executive Officer. "Each year in the United States there are approximately 11,000 surgeries performed to treat malignant brain cancer. Prior to this approval, only those patients who suffered recurrence of glioblastoma multiforme and required a second surgery could benefit from treatment with GLIADEL(R) Wafer. With an expanded label indication that provides for administration of GLIADEL(R) Wafer at the time of initial surgery, followed by radiation, the benefits of GLIADEL(R) Wafer will now be available to a broader number of patients."
"We intend to initiate a new product launch in the United States to raise awareness among neurosurgeons, neuro-oncologists and patients of the benefits associated with GLIADEL(R) Wafer during initial surgery," Dr. Smith continued. "Over the coming weeks, we also intend to resubmit our European regulatory application for GLIADEL(R) Wafer seeking approval for use in initial surgery in Europe so that we can offer the benefits of GLIADEL(R) Wafer to an even larger population."
Clinical Program Background
A Phase III double blind, placebo-controlled clinical study of GLIADEL(R) Wafer was conducted at 38 centers in 14 countries. A total of 240 adult men and women undergoing initial surgical resection of a high-grade malignant glioma were enrolled and randomly assigned to receive implantation of either GLIADEL(R) Wafers or placebo wafers into the resection cavity followed about two weeks later by radiation therapy. The primary end-point for the trial was survival.
Long-Term Survival Results
Complete follow up for as long as 48 months was obtained for 239 of the 240 patients. Of the 11 patients known to be alive on the date of last follow up, 9 received GLIADEL(R) Wafer and 2 received placebo. Survival was prolonged in the GLIADEL(R) Wafer treatment group (median survival increased to 13.9 months from 11.6 months, p<0.05). The overall risk of dying during 3-4 years after treatment was reduced in the GLIADEL(R) Wafer treatment group, as reflected by a hazard ratio of 0.73 (95% CI: 0.56-0.95; p<0.05).
Safety Information
Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL(R) Wafer should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL(R) Wafer, including one case leading to brain herniation. GLIADEL(R) Wafer contains carmustine and should not be given to patients who are allergic to carmustine. Carmustine can also cause fetal harm when administered to a pregnant woman.
About GLIADEL(R) Wafer
GLIADEL(R) Wafer is the only marketed cancer treatment capable of delivering chemotherapy directly to the site of a brain cancer, bypassing the blood-brain barrier and minimizing drug exposure to other areas of the body. GLIADEL(R) Wafer is a small, white to off-white dime-sized wafer comprised of a biodegradable polymer (polifeprosan 20) incorporating 7.7 mg. of carmustine (BCNU), a chemotherapeutic agent usually administered intravenously to treat a malignant glioma. Up to eight GLIADEL(R) Wafers can be implanted in the cavity created when a surgeon removes a brain tumor. There, they slowly dissolve, releasing BCNU directly to the tumor site in high concentrations, while minimizing drug exposure to other areas of the body.
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