Schering-Plough says that the US Food and Drug Administration has approved its brain cancer drug, Temodar (temozolomide), for use in combination with radiotherapy for the treatment of adults with newly-diagnosed glioblastoma multiforme – a form of malignant brain tumour.

Approval, which was based on Phase III data showing that those treated with Temodar in combination with radiotherapy, lived an average of 14.6 months, versus 12.1 months for those receiving radiation alone, comes just four months after the product was granted fast track approval status in the US in this new indication [[01/11/04e]]. The compound also boasts US orphan drug status, which entitles it to seven years’ marketing exclusivity.

“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.”

First approved in 1999, Temodar is one of only a few treatment options for patients with glioblastoma multiforme – the third leading cause of cancer death in adults aged 20 to 29. S-P says that it is broadening its oncology portfolio and notes that Temodar brought in global sales of some $459 million dollars in 2004. The company has filed an application for the drug in the European Union – where it is known as Temodal – in a similar indication [[03/11/04g]], and chief executive, Fred Hassan, recently said it was one compound that investors should keep their eyes on [[06/01/05a]].