FDA has approved temozolomide, a cancer treatment for adult patients diagnosed with a form of brain cancer -- anaplastic astrocytoma -- who have relapsed following chemotherapy including a nitrosourea drug (carmustine or lomustine) and procarbazine. The following may be used to respond to questions. Approximately 18,000 new cases of primary intracranial (brain) cancer are diagnosed each year in the U.S. This represents about 2 percent of all adult cancers. More than 50 percent of these are high-grade gliomas (i.e. glioblastoma multiform and anaplastic astrocytoma tumors). Patients with these tumors often suffer from severe disabilities such as motor dysfunction, seizures, and vision abnormalities. The approval of temozolomide gives patients another option for treatment of their disease when they do not respond to initial treatment with radiation and chemotherapy. Temozolomide has been granted accelerated approval - a regulatory mechanism that allows early approval for a product for the treatment of serious or life-threatening conditions for which no acceptable alternative treatments exist or which provide a meaningful therapeutic benefit over existing treatments. Accelerated approval is based on surrogate markers of effectiveness such as shrinkage of a tumor rather than a documented effect on clinical benefit such as survival or quality of life. Temozolomide's approval was supported by a single arm multi-center trial in l62 patients who had anaplastic astrocytoma at first relapse and who had received previous radiation therapy and may also have received chemotherapy. In the patients with tumors resistant to previous chemotherapy with a nitrosourea and procarbazine, seven (7) out of 54 patients (13 percent) had partial shrinkage of their tumors while nine percent or 5 out of 54 patients had a complete response. Side effects reported include headaches, nausea, vomiting, fatigue and low blood counts. Patients with severe vomiting may require antiemetic therapy before or during temozolomide treatment. FDA's approval follows the recommendation of the Oncologic Drugs Advisory Committee for accelerated approval of temozolomide to treat patients with anaplastic astrocytoma tumors. Temozolomide was granted orphan drug status in 1998. Orphan status provides incentives to companies to develop products for use in small patient populations. The drug will be marketed under the name Temodar. As a condition of approval, the manufacturer, Schering-Plough Corp, Madison New Jersey will conduct a randomized trial to evaluate clinical benefit.