Schering's Bonefos Won't Get FDA Approval Without Additional Trial Data

The FDA will not consider approving Schering AG's breast cancer drug Bonefos until after the results of a Phase III clinical trial are reported, the company said.

Berlex, Schering AG's U.S. affiliate, said the FDA won't review its new drug application (NDA) for Bonefos (clodronate) until it has completed the National Surgical Adjuvant Breast and Bowel Project B-34 study, which started last March. Final results from the Phase III trial are expected in 2008, said Berlex, which recently met with the FDA to discuss the Bonefos NDA.

The FDA issued Berlex an approvable letter for Bonefos in January, indicating it needed more information about the drug. Berlex is seeking approval for Bonefos as an adjuvant oral treatment to reduce the occurrence of bone metastases in Stage II/III breast cancer patients.