Schering-Plough says that the European regulatory authority has given the green light to Temodal (temozolomide) for the first-line treatment of patients with newly diagnosed glioblastoma multiforme – the most common and aggressive form of primary brain cancer. The move follows a positive opinion from the CHMP in April [[25/04/05g]].
The new approval is based largely on data from a 573-patient Phase III trial, which showed that twice as many newly diagnosed GBM patients treated with Temodal survived two years or longer, versus 10% of those receiving radiotherapy alone.
Expanding the product’s label will certainly provide a boon to S-P, as it was previously only registered for use in patients who had failed on standard therapy. Temodal won full US approval in March 2005 – where it is known as Temodar – for the treatment of adult patients with newly diagnosed GBM when administered in combination with radiotherapy and then as maintenance therapy [[17/03/05c]].
GBM is the most common and deadliest type of primary brain tumour and is more common among males and occurs more frequently in Caucasians. The average age at diagnosis is 50 to 60 years, with an estimated 10,000 patients being diagnosed in Europe each year.