Schering-Plough today reported that the U.S. Food and Drug Administration (FDA) has granted approval for Temodar (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.
The approval was based on data that demonstrated a significant overall survival benefit in patients who were treated with Temodar in combination with radiotherapy. Concurrent with the approval for newly diagnosed GBM, Temodar also received full approval for the treatment of adult patients with refractory anaplastic astrocytoma (AA), another form of brain tumor. Temodar received accelerated approval for AA in 1999 and is currently marketed for this indication in the United States.
"Temodar represents an important component for patients and physicians in the fight against GBM and validates the real benefits of chemotherapy in treating this disease," said Dr. Henry Friedman, co-director, Clinical Neuro-Oncology Program, The Brain Tumor Center at Duke. "After 26 years of practicing neuro-oncology, I view Temodar as a significant advancement in battling GBM."
The full approval of Temodar follows a priority review of the supplemental new drug application containing the GBM data that was submitted in September 2004. FDA grants priority review status to drugs that, if approved, would address unmet medical needs and represent significant advances over existing treatments.
"We are very pleased with today's FDA action and what it means for patients with GBM, the most serious and aggressive type of malignant brain tumor," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "This approval represents a significant advance in the treatment of brain cancer, a disease for which few effective treatments exist."