Wed Mar 16, 2005 6:14 PM GMT
By Ransdell Pierson
NEW YORK (Reuters) - Schering-Plough Corp.,. on Wednesday said U.S. regulators had approved earlier use of its brain cancer drug Temodar following a trial that last year showed it prolonged lives of patients.
The FDA action will allow the company to market the capsules, with simultaneous use of radiation, to adults newly diagnosed with glioblastoma multiforme, the most deadly form of malignant brain cancer.
Temodar, which Schering-Plough launched in 1999, is the only widely used drug for the aggressive form of brain cancer, which usually kills patients within a year. But it typically has not been used until months after patients have received radiation and their tumors returned.
The expanded indication will now allow it to be used immediately after diagnosis, along with radiation, rather than after tumors recur. The previous standard of treatment has been radiation alone after diagnosis.
Sales of Temodar have grown significantly since trial data were released last June showing that patients with the cancer who received it and radiation lived longer than those who received radiation alone.
It was the first time a drug improved survival in such patients, researchers said.
Two years after treatment, 27 percent of those taking Temodar and radiation in the trial were still alive, compared with only 10 percent getting radiation alone.
In the international trial, tumors did not recur after two years in 11 percent of patients in the Temodar group.
But only 2 percent of those getting radiation alone had no progression of the disease, which kills an estimated 10,000 Americans annually and an equal number in Europe.
Schering-Plough Chief Executive Fred Hassan on Tuesday told Reuters he is counting on growing sales of Temodar, along with higher demand for the company's cholesterol fighters and Nasonex nasal allergy spray, to help him turn around the struggling drugmaker this year.
Fourth-quarter sales of Temodar jumped 72 percent to $150 million. (Additional reporting by Julie Steenhuysen in Chicago)
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