al from Canada
02-03-2006, 08:58 PM
http://www.schering-plough.com/images/spacer.gifHealth Canada Approves TEMODAL(R)(temozolomide) for Patients With Newly Diagnosed Glioblastoma Multiforme
KENILWORTH, N.J., Feb. 2 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported that Health Canada has granted approval for TEMODAL(R)(temozolomide) Capsules for use in combination with radiotherapy for the treatment of adult patients with newly diagnosed glioblastoma multiforme (GBM), a form of malignant brain cancer. TEMODAL is currently marketed in Canada for the treatment of recurrent or progressive GBM or anaplastic astrocytoma (AA), another form of brain tumor.
"In a disease for which few effective treatments exist, TEMODAL is an important component for the treatment of GBM, the most serious and aggressive type of malignant brain tumor," said Dr. Warren P. Mason, Associate Professor, Department of Medicine, University of Toronto, and medical director of the Pencer Brain Tumour Cancer Centre at Princess Margaret Hospital. "This approval provides newly diagnosed GBM patients and their families additional hope in the battle against this devastating disease."
The new indication of TEMODAL follows a priority review of the supplemental new drug submission containing the GBM data that was submitted in June 2005. The approval of TEMODAL for newly diagnosed GBM was based on efficacy and safety data from a landmark Phase III study conducted by the National Cancer Institute of Canada (NCIC) and European Organisation for Research and Treatment of Cancer (EORTC) in patients with newly diagnosed GBM. These data were published in the March 10, 2005 edition of the New England Journal of Medicine. In this multicenter trial of 573 patients, significant improvements in overall survival were observed in patients who were treated with TEMODAL in combination with radiotherapy.
TEMODAL is now indicated for use in adult patients with newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment after the patient has completed radiotherapy. In patients with refractory GBM or AA, TEMODAL is indicated for use in adult patients who have documented evidence of recurrence or progression after standard therapy.
About Temozolomide
Temozolomide is an oral, cytotoxic alkylating agent. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumors. TEMODAL was initially approved in the European Union (EU) in 1999 for the treatment of patients with malignant glioma, such as GBM or anaplastic astrocytoma, showing recurrence or progression after standard therapy. In June 2005, TEMODAL received marketing approval in the EU for the treatment of patients with newly diagnosed GBM concomitantly with radiotherapy and subsequently as monotherapy treatment. Schering-Plough markets temozolomide in the United States as TEMODAR(R) Capsules. Schering-Plough received accelerated approval in the US for relapsed refractory AA in 1999 and full approval of TEMODAR from the U.S. Food and Drug Administration (FDA) in March 2005 for relapsed refractory AA and for the treatment of newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment. The development of temozolomide for additional markets and expanded indications is consistent with Schering-Plough's strategy to broaden its oncology portfolio and is in line with its plans to build strength in its global franchises through both internal research and external collaborations and licensing opportunities.
About Gliomas
Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are high-grade gliomas (brain tumors). GBM is a rapidly growing neuroglia cell tumor of the central nervous system, most often located in the cerebrum. It is the most common and deadliest type of primary brain tumor. GBM is more common among males and occurs more frequently in Caucasians. It is the third leading cause of cancer-related death in young adults age 20 to 29. The median age at which people are diagnosed with GBM is 50 to 60 years. The annual incidence of GBM is four to five cases per 100,000 persons, with 8,000 to 10,000 new cases diagnosed per year in North America.
Anaplastic astrocytoma (AA) is the second most common type of brain tumor and can progress to become GBM. It is a particularly aggressive tumor with few treatments available. The median age at which people are diagnosed with AA is 40 to 50 years. The annual incidence of AA is one to 1.5 cases per 100,000 persons, with 2,000 to 3,000 new cases diagnosed per year in North America.
Important Information Regarding U.S. Labeling for TEMODAR in Adult Patients with Newly Diagnosed GBM
Patients treated with TEMODAR Capsules may experience myelosuppression. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression. TEMODAR Capsules are contraindicated in patients who have a history of hypersensitivity to any of its components, or to dacarbazine (DTIC). Caution should be exercised when administered to those with severe hepatic or renal impairment. TEMODAR may cause fetal harm when administered to a pregnant woman. Nursing should be discontinued in women receiving TEMODAR. The effectiveness of TEMODAR in children has not been established. TEMODAR Capsules should not be opened or chewed. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes. Prophylaxis against Pneumocystis carinii pneumonia (PCP) is required in all patients receiving TEMODAR in combination with radiotherapy for the 42-day regimen. There may be a higher occurrence of PCP when temozolomide is administered during a longer dosing regimen. All patients receiving TEMODAR, particularly patients receiving steroids, should be observed closely for the development of PCP regardless of the regimen. As noted in the U.S. package insert, during the concomitant phase (TEMODAR + radiotherapy), adverse events including thrombocytopenia, nausea, vomiting, loss of appetite and constipation, were more frequent in the TEMODAR + radiotherapy arm versus the radiotherapy arm alone. The incidence of other adverse events was comparable in the two arms. The most common adverse events across the cumulative TEMODAR experience were hair loss, nausea, vomiting, decrease in appetite, headache and constipation.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., USA, and its Web site is http://www.schering-plough.com (http://www.schering-plough.com/).
SOURCE Schering-Plough Corporation
02/02/2006
CONTACT: Media: Matthew J. Scampoli, +1-908-298-4812, or Gail Thornton, +1-908-298-5313, or Investors: Alex Kelly, +1-908-298-7436, all of Schering-Plough
Web site: http://www.schering-plough.com (http://www.schering-plough.com/)
(SGP)
KENILWORTH, N.J., Feb. 2 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported that Health Canada has granted approval for TEMODAL(R)(temozolomide) Capsules for use in combination with radiotherapy for the treatment of adult patients with newly diagnosed glioblastoma multiforme (GBM), a form of malignant brain cancer. TEMODAL is currently marketed in Canada for the treatment of recurrent or progressive GBM or anaplastic astrocytoma (AA), another form of brain tumor.
"In a disease for which few effective treatments exist, TEMODAL is an important component for the treatment of GBM, the most serious and aggressive type of malignant brain tumor," said Dr. Warren P. Mason, Associate Professor, Department of Medicine, University of Toronto, and medical director of the Pencer Brain Tumour Cancer Centre at Princess Margaret Hospital. "This approval provides newly diagnosed GBM patients and their families additional hope in the battle against this devastating disease."
The new indication of TEMODAL follows a priority review of the supplemental new drug submission containing the GBM data that was submitted in June 2005. The approval of TEMODAL for newly diagnosed GBM was based on efficacy and safety data from a landmark Phase III study conducted by the National Cancer Institute of Canada (NCIC) and European Organisation for Research and Treatment of Cancer (EORTC) in patients with newly diagnosed GBM. These data were published in the March 10, 2005 edition of the New England Journal of Medicine. In this multicenter trial of 573 patients, significant improvements in overall survival were observed in patients who were treated with TEMODAL in combination with radiotherapy.
TEMODAL is now indicated for use in adult patients with newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment after the patient has completed radiotherapy. In patients with refractory GBM or AA, TEMODAL is indicated for use in adult patients who have documented evidence of recurrence or progression after standard therapy.
About Temozolomide
Temozolomide is an oral, cytotoxic alkylating agent. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumors. TEMODAL was initially approved in the European Union (EU) in 1999 for the treatment of patients with malignant glioma, such as GBM or anaplastic astrocytoma, showing recurrence or progression after standard therapy. In June 2005, TEMODAL received marketing approval in the EU for the treatment of patients with newly diagnosed GBM concomitantly with radiotherapy and subsequently as monotherapy treatment. Schering-Plough markets temozolomide in the United States as TEMODAR(R) Capsules. Schering-Plough received accelerated approval in the US for relapsed refractory AA in 1999 and full approval of TEMODAR from the U.S. Food and Drug Administration (FDA) in March 2005 for relapsed refractory AA and for the treatment of newly diagnosed GBM concomitantly with radiotherapy and then as maintenance treatment. The development of temozolomide for additional markets and expanded indications is consistent with Schering-Plough's strategy to broaden its oncology portfolio and is in line with its plans to build strength in its global franchises through both internal research and external collaborations and licensing opportunities.
About Gliomas
Glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are high-grade gliomas (brain tumors). GBM is a rapidly growing neuroglia cell tumor of the central nervous system, most often located in the cerebrum. It is the most common and deadliest type of primary brain tumor. GBM is more common among males and occurs more frequently in Caucasians. It is the third leading cause of cancer-related death in young adults age 20 to 29. The median age at which people are diagnosed with GBM is 50 to 60 years. The annual incidence of GBM is four to five cases per 100,000 persons, with 8,000 to 10,000 new cases diagnosed per year in North America.
Anaplastic astrocytoma (AA) is the second most common type of brain tumor and can progress to become GBM. It is a particularly aggressive tumor with few treatments available. The median age at which people are diagnosed with AA is 40 to 50 years. The annual incidence of AA is one to 1.5 cases per 100,000 persons, with 2,000 to 3,000 new cases diagnosed per year in North America.
Important Information Regarding U.S. Labeling for TEMODAR in Adult Patients with Newly Diagnosed GBM
Patients treated with TEMODAR Capsules may experience myelosuppression. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression. TEMODAR Capsules are contraindicated in patients who have a history of hypersensitivity to any of its components, or to dacarbazine (DTIC). Caution should be exercised when administered to those with severe hepatic or renal impairment. TEMODAR may cause fetal harm when administered to a pregnant woman. Nursing should be discontinued in women receiving TEMODAR. The effectiveness of TEMODAR in children has not been established. TEMODAR Capsules should not be opened or chewed. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes. Prophylaxis against Pneumocystis carinii pneumonia (PCP) is required in all patients receiving TEMODAR in combination with radiotherapy for the 42-day regimen. There may be a higher occurrence of PCP when temozolomide is administered during a longer dosing regimen. All patients receiving TEMODAR, particularly patients receiving steroids, should be observed closely for the development of PCP regardless of the regimen. As noted in the U.S. package insert, during the concomitant phase (TEMODAR + radiotherapy), adverse events including thrombocytopenia, nausea, vomiting, loss of appetite and constipation, were more frequent in the TEMODAR + radiotherapy arm versus the radiotherapy arm alone. The incidence of other adverse events was comparable in the two arms. The most common adverse events across the cumulative TEMODAR experience were hair loss, nausea, vomiting, decrease in appetite, headache and constipation.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., USA, and its Web site is http://www.schering-plough.com (http://www.schering-plough.com/).
SOURCE Schering-Plough Corporation
02/02/2006
CONTACT: Media: Matthew J. Scampoli, +1-908-298-4812, or Gail Thornton, +1-908-298-5313, or Investors: Alex Kelly, +1-908-298-7436, all of Schering-Plough
Web site: http://www.schering-plough.com (http://www.schering-plough.com/)
(SGP)