Ciba/Chiron's Aredia Backed By FDA Panel

Ciba and Chiron have been given a positive verdict from the US Food and Drug Administration's Oncologic Drugs Advisory Committee for their application to market Aredia (pamidronate) for the prevention of bone metastases in patients with multiple myeloma. The product is already approved for Paget's disease and severe hypercalcemia associated with malignancy.

The panel found that the bisphosphonate drug was clearly effective for preventing metastases in patients with at least one osteolytic lesion, but asked the company to provide more data on the optimal duration of Aredia therapy (particularly beyond the nine months' follow-up in the submitted Phase III study) and the timing of initial therapy, and to further define the optimal dosing schedule. A Ciba spokesman told the panel that data from a second stage of the trial would provide data up to 21 months, and was under analysis. Ciba is also testing Aredia in breast cancer patients.