SCHERING'S BREAST CANCER DRUG BONEFOS GETS 'APPROVABLE LETTER'

The FDA has issued an "approvable letter" for Schering's drug Bonefos, which is intended to reduce the occurrence of bone cancer in patients who have had breast cancer surgery.

The agency's move will delay marketing of Bonefos (clodronate) for this indication, as the FDA seeks additional information from the company about the drug. Bonefos, which is currently approved for treating high levels of calcium in the blood caused by cancer, had been widely expected to receive final approval for the new use.

Schering did not say what new information the FDA has required. Schering's U.S. affiliate, Berlex, plans to request a meeting with the FDA to discuss the information that is needed to obtain approval. The firm will submit this information as quickly as possible, Berlex said.
"We look forward to the opportunity to meet with the FDA so we can advance the approval process," said Marc Rubin, a member of Schering's board of executive directors responsible for development and oncology.