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Further Trial Data Needed Before FDA Approves Clodronate
At a recent meeting with the U.S. Food and Drug Administration (FDA) the agency indicated that it would not consider approving Bonefos for marketing until results from the ongoing NSABP B-34 trial are known. Final results from that trial, which has completed enrollment of 3,323 women with breast cancer in March 2004, are expected in 2008.
Berlex, Inc., a U.S. affiliate of Schering AG, submitted an NDA for the use of Bonefos in the United States as an adjuvant oral treatment for reducing the occurrence of bone metastases in Stage II/III breast cancer patients and had received an approvable letter for Bonefos from the FDA on January 6, 2005.
“Given the added direction that was provided at our recent discussion with the FDA, we now will focus our attention on the results that the NSABP study will provide to help us chart the future course for Bonefos,” said Carlo Montagner, Head Global Business Unit Oncology. “Based on the broad clinical experience with Bonefos in many countries, and the fact that there is a significant unmet medical need, we remain hopeful about options to make Bonefos available as an adjuvant oral treatment for patients with breast cancer.”
Oral Bonefos is approved in 67 countries outside the Unites States largely for the treatment of tumor-induced osteolysis and hypercalcemia. So far, nearly 20 years of use and 300,000 patient-years of experience with Bonefos have been accumulated worldwide.
Source: Schering AG