Merridith
06-02-2004, 01:14 AM
The FDA decision came as a surprise as an advisory panel recommended the drug, known as RSR13, not be approved as the population of patients in question was a sub-group of an unsuccessful earlier trial.
That trial, of brain cancer, failed last year to show any significant difference between patients treated with radiation and those treated with radiation and Allos's drug.
However, it appeared that a sub-group of patients whose brain tumors originated in breast cancer were helped. The median survival time was 5.9 months for patients on the combination treatment versus 4.5 months in patients on radiation alone.
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That trial, of brain cancer, failed last year to show any significant difference between patients treated with radiation and those treated with radiation and Allos's drug.
However, it appeared that a sub-group of patients whose brain tumors originated in breast cancer were helped. The median survival time was 5.9 months for patients on the combination treatment versus 4.5 months in patients on radiation alone.
Read the full article at: