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Indevus Pharmaceuticals' Valstar (valrubicin), originally developed by Anthra, was launched in the US for the treatment of Bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ (CIS) of the bladder in 1998. Valstar's initial approval was based on a clinical trial in which 90 BCG-refractory CIS patients who had received at least two previous lines of treatment (including BCG) received Valstar after primary tumor resection. The complete response rate was 18% and the median duration of response was 21 months. In 2002, however, Valstar was pulled from the market due to concerns over the purity of the original drug formulation.
Valstar is an anthracycline analog that causes chromosomal damage by interfering with DNA topoisomerase II, an enzyme responsible for DNA breaking and repair during cell replication.
Bladder cancer's prevalence is high, with over 1.1 million bladder cancer patients worldwide. Indeed, Datamonitor forecasts that by 2009 the incidence of bladder cancer will reach over 164,700 in the seven major markets. There is a high unmet need in the treatment of recurrent CIS bladder tumors because, generally, they do not respond well to chemotherapy. BCG immunotherapy shows the best efficacy against recurrent CIS bladder tumors, but patients often show poor response or become refractory to treatment.
Valstar's reintroduction into the bladder cancer market will provide a treatment option for the currently underserved BCG-refractory patients. Prior to its withdrawal from the market, Valstar was widely used in this patient population, gaining physician familiarity. Since no other drugs have been approved for use in this patient population since its withdrawal, Valstar's uptake should be swift. However, the drug could face competition from Urocidin (MCC; Bioniche) in the future. Urocidin is a sterile mycobacterial cell wall-DNA complex that is currently in Phase III trials for BCG-refractory bladder cancer patients. With this Phase III trial due for completion in 2010, Indevus must invest considerable resources in quickly reestablishing a strong market position for Valstar in the bladder cancer market.
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