Temozolomide: Press Release
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----- Schering-Plough Announces FDA Approval of TEMODAR(TM) (Temozolomide) Capsules For Patients With Refractory Anaplastic Astrocytoma

First New Chemotherapy Agent for Brain Tumors in 20 Years

MADISON, N.J., Aug. 11 /PRNewswire/ -- Schering-Plough Corporation (NYSE: SGP ) today announced that the U.S. Food and Drug Administration has granted accelerated approval to TEMODAR(TM) (temozolomide) Capsules for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse with disease progression on a nitrosourea- and procarbazine-containing drug regimen. TEMODAR is the first new chemotherapy agent for this type of brain tumor approved in the United States in 20 years.

It will be available nationwide in early September.

"TEMODAR represents an important new treatment option in recurrent anaplastic astrocytoma, one of the most serious and aggressive types of malignant brain tumor," said W.K. Alfred Yung, M.D., chairman of the Neuro- Oncology Department at MD Anderson Cancer Center in Houston. "In addition, oral dosing with TEMODAR Capsules for 5 days in each 28-day treatment cycle is convenient for patients, enabling them to take medication in the comfort of their homes instead of at doctors' offices or hospitals where intravenous treatments are administered," Yung said.

TEMODAR, an oral cytotoxic alkylating agent, is the lead compound in a new class of compounds known as imidazotetrazines. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumors. Schering-Plough has exclusive worldwide rights to market temozolomide through a licensing agreement with Cancer Research Campaign Technology, Ltd., of the United Kingdom. In the European Union, temozolomide is approved under the name TEMODAL(R) Capsules.

The median survival time for patients with anaplastic astrocytoma ranges from 2 to 3 years from the time of initial diagnosis. Despite intensive treatment with surgery, radiotherapy and chemotherapy, these patients almost invariably experience tumor recurrence, often within a year of completing first-line therapy. The annual incidence of anaplastic astrocytoma in the United States is one to 1.5 cases per 100,000 persons, with 2,000 to 3,000 new cases diagnosed per year.


A single-arm, multicenter clinical study with TEMODAR(TM) (temozolomide) Capsules was conducted in 162 patients who had anaplastic astrocytoma at first relapse. Patients had previously received radiation therapy and may also have previously received a nitrosourea with or without other chemotherapy. Of the 162 patients in the study, 54 patients had disease progression on prior therapy with both a nitrosourea and procarbazine and their malignancy was considered refractory to chemotherapy (refractory anaplastic astrocytoma population). Patients in the study were given TEMODAR for the first 5 days of a 28-day treatment cycle at a starting dose of 150 mg/m2 per day. In the refractory anaplastic astrocytoma population, the overall tumor response rate (complete response plus partial response) was 22 percent (12/54 patients) and the complete response rate was 9 percent (5/54 patients).

A complete response equaled complete resolution of the tumor for 2 consecutive months as measured by gadolinium-enhanced magnetic resonance and clinical improvement. A decrease of more than 50 percent in the tumor area for 2 consecutive months constituted a partial response.

The median duration of all responses was 50 weeks (range of 16 weeks to 114 weeks) and the median duration of complete responses was 64 weeks (range of 52 weeks to 114 weeks). Progression-free survival at six months was 45 percent (95 percent confidence interval of 31 percent to 58 percent), progression-free survival at 12 months was 29 percent (95 percent confidence interval of 16 percent to 42 percent), and median progression-free survival was 4.4 months. Overall survival at six months was 74 percent (95 percent confidence interval of 62 percent to 86 percent), overall survival at 12 months was 65 percent (95 percent confidence interval of 52 percent to 78 percent), and median overall survival was 15.9 months. vTEMODAR(TM) (temozolomide) Capsules is indicated for the treatment of refractory anaplastic astrocytoma based on a demonstrated tumor response rate.

No results are available from randomized, controlled trials in recurrent anaplastic astrocytoma that demonstrate a clinical benefit resulting from treatment, such as improvement in disease-related symptoms, delayed disease progression or improved survival.

In the clinical study, myelosuppression (thrombocytopenia and neutropenia) was the dose-limiting adverse event. The effect usually occurred within the first few cycles of therapy, was not cumulative and was resolved within 14 days. Hospitalization, blood transfusion and discontinuation of therapy due to myelosuppression occurred in less than 10 percent of patients treated with temozolomide. The most common side effects were nausea (53 percent), vomiting (42 percent), headache (41 percent), fatigue (34 percent) and constipation (33 percent). Each of these side effects was severe in 10 percent or less of patients, with nausea and vomiting readily controlled by standard antiemetic therapy.

Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

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