ROCKVILLE, Md--In a move with very little precedent, the FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of a new indication for the bisphosphonate Aredia (pam-idronate disodium for injection) on the basis of a single clinical trial.
The new indication is for the treatment of bone metastases associated with multiple myeloma. The drug is already approved for use in hypercalcemia of malignancy (October 1991) and Paget's disease (September 1994).
The committee felt that even though the drug's sponsor, Ciba Pharmaceutical Division, Ciba-Geigy Corp., presented only one phase III clinical trial, the need for the drug is so great and the adverse reactions sufficiently tolerable, that Aredia should be made available to people with multiple myeloma.
James Berenson, MD, associate professor of medicine, University of California, Los Angeles, and chief of oncology, Veterans Administration Medical Center, told the panel that multiple myeloma is the second most common hematologic malignancy in the United States, with 12,500 new cases each year. Sixty percent of patients are already at stage III when they are first diagnosed.
Among the many clinical features of multiple myeloma are serious skeletal complications such as osteoporosis, lytic lesions, pathologic fractures, osteopenia, and spinal cord compression. Treatment with analgesics, radiation therapy, surgery, glucocorticosteroids, and chemotherapy has been less than successful, Dr. Berenson said.
John Seaman, PharmD, director of clinical research, Ciba Pharmaceuticals Division, described the randomized, double-blind clinical trial of Aredia vs placebo in which 392 patients with stage III multiple myeloma participated. All had at least one lytic lesion.
The goal was to compare the effects of Aredia and placebo on spinal cord compression or collapse, pathologic fracture, and need for radiation to treat bone and prevent fractures. Pain, narcotic use, bone lesion response, and quality of life also were evaluated. In general, all patients were receiving appropriate anticancer drugs, most commonly melphalan(Drug information on melphalan) (Alkeran) and prednisone(Drug information on prednisone).