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Drug okayed for carcinoma in situ
ROCKVILLE, Md.-The FDA has approved an orphan drug for BCG-refractory transitional-cell bladder cancer when immediate cystectomy isn’t possible.
In a study accepted by the FDA, valrubicin (Valstar, Medeva) produced a complete response at six months in 16 of 90 patients who’d failed BCG and other agents. Median duration of response to last negative bladder biopsy was 13.5 months and 21 months until documented recurrence. Valrubicin, a semisynthetic anthracycline, is given intravesically.
Because only about 18% of patients have a complete response, the drugmaker advised physicians to inform patients that delaying cystectomy beyond the three months needed to determine complete response or recurrence could increase the risk of metastasis.
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