Breast Cancer

Bonefos approved as adjuvant treatment of breast cancer

Published in Cancer Weekly, February 8th, 2005

Schering AG, Germany (SCH, SHR) announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for Bonefos (clodronate), an oral non-amino bisphosphonate intended to reduce the occurrence of bone metastases in the post-surgical (adjuvant) treatment of breast cancer patients.

Berlex, Inc., Schering's U.S. affiliate, plans to request a meeting with the FDA to discuss the information that is needed to obtain approval, and will submit this information as quickly as possible.

"We look forward to the opportunity to meet with the FDA so we can advance the approval process," said Marc Rubin, MD, member of the Schering AG board of...

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Source: Cancer Weekly (2005-02-08)

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