KENILWORTH, N.J., July 31 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that the Japan Ministry of Health, Labor and Welfare (MHLW) has approved TEMODAL(R) (temozolomide) Capsules for the treatment of malignant glioma.
The approval of TEMODAL by the MHLW follows a priority review of the New Drug Application (J-NDA) submission, which was granted in September of 2005 in order to satisfy an unmet medical need in Japanese patients. TEMODAL, marketed as TEMODAR(R) in the US, is approved in 77 countries.
TEMODAL will become available upon determination of pricing by the Japanese Ministry of Health, Labor and Welfare.
“TEMODAL is a valuable treatment that offers hope to people with malignant glioma,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “Japanese patients who are diagnosed with this devastating disease will now have an important new treatment option.”
In Japan, TEMODAL is indicated for both treatment-naive newly-diagnosed patients (in combination with radiotherapy), and previously treated patients with malignant gliomas. The usual starting dose of TEMODAL for newly diagnosed patients in Japan is 75 mg/m2 once daily for 42 consecutive days in combination with radiotherapy. After a 4-week rest period, temozolomide monotherapy is started at 150 mg/m2 orally once daily for 5 consecutive days per 28-day treatment cycle. The dose may be increased to 200 mg/m2 for the next 28-day treatment cycle if the initial dose of 150 mg/m2 is tolerated. For previously treated patients, the usual starting dose is monotherapy at 150 mg/m2 (body surface area) as TEMODAL orally once daily for 5 consecutive days per 28-day treatment cycle. The dose may be increased to 200 mg/m2 for the next 28-day treatment cycle if the initial dose of 150 mg/m2 is tolerated. TEMODAL will be available in Japan as 20 mg and 100 mg capsule strengths.
Malignant gliomas are primary brain tumors that develop from glial cells. Approximately 30 percent of primary brain tumors are gliomas, which affect approximately six to eight people per 100,000 people worldwide. Both glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are types of high-grade gliomas. GBM is the most common and aggressive form of primary brain tumor. Approximately 2,500 patients are diagnosed with malignant glioma in Japan each year.(1)
The approval for TEMODAL is based on efficacy and safety data from six studies including a study of 32 Japanese patients with recurrent AA, and a Phase III study conducted by the European Organisation for Research and Treatment of Cancer (EORTC) and the National Cancer Institute of Canada (NCIC). The Phase III study, described in a publication in the March 10, 2005 edition of the New England Journal of Medicine, involved 573 patients with newly diagnosed GBM and demonstrated longer survival in the patients who received TEMODAL and radiation compared with those who received only radiation.
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 received accelerated approval in the US for refractory AA in 1999 and full approval of temozolomide (TEMODAR) from the U.S. Food and Drug Administration (FDA) in March 2005 for 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.
Important Information Regarding U.S. Labeling for TEMODAR
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 with or without RT. 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, fatigue, nausea, vomiting, decrease in appetite, headache and constipation.
About Schering-Plough
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 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to TEMODAL and the potential market for TEMODAL. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company’s 2005 10-K.
For more information, visit: http://www.schering-plough.com.
(1) Neurologia Medico-Chirurgica, Suppl., Vol.43, September, 2003
Schering-Plough Corporation
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