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FDA OKs Schering-Plough Brain Cancer Drug

The U.S. Food and Drug Administration (FDA) has approved Schering-Plough's Temodar for the treatment of brain cancer. About 18,000 brain cancer cases are diagnosed in the U.S. each year, and brain cancer currently accounts for about 2% of all adult cancers. The Madison, N.J.-based drug maker's cancer drug was approved under the accelerated program for the treatment of those patients who have not initially responded to radiation and chemotherapy, the FDA says. The accelerated approval was based on clinical markers showing that Temodar could shrink the size of patients' brain tumors rather than any documented effect on survivability or improvements in cancer patients' quality of life, the FDA says. The support for Temodar's accelerated approval was a single trial of 162 patients in which it was demonstrated that 13% of the 54 patients with tumors resistant to chemotherapy experience a partial shrinkage of their tumors, the FDA says. But the use of this drug carries some risks, the FDA warned. The side effects reported during that one clinical trial included headaches, nausea, vomiting, fatigue, and low blood counts. In addition, the FDA noted, patients with severe vomiting required anti-vomiting drugs during their course of treatment. The FDA approval follows a meeting of the agency's Oncologic Drugs Advisory Committee, which recommended Temodar for accelerated approval. Temodar had received orphan drug status in 1998, allowing for its use in small patient populations.

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