ROCKVILLE, MarylandMembers of the Oncologic Drugs Advisory Committee (ODAC) have unanimously recommended that the Food and Drug Administration approve Zometa (zoledronic acid for injection, Novartis) for the treatment of bone metastases in patients with multiple myeloma and breast cancer, prostate cancer, lung cancer, and other solid tumors.
The FDA brought Zometa before ODAC in part because its own oncology division was uncertain about granting such broad approval to the drug.
The 11-to-0 vote came after lengthy presentations by Novartis and FDA medical reviewers and discussions about the merits and meaning of three studies that involved more than 3,000 patients, which the drug company presented to support its application.
"Zometa, given at a dose of 4 mg every 3 to 4 weeks, is bone specific, not tumor specific," said Burkhard Daldrup, PhD, global head of drug regulatory affairs for Novartis’ oncology business unit. "Evidence shows its effectiveness in a broad variety of different tumor types."
Zometa is a new generation of intravenous bisphosphonates, a family of drugs that can inhibit bone resorption. Animal and human studies show Zometa can delay or reduce the occurrence of skeletal-related events (SREs)which include pathologic fractures, radiation therapy to bone, bone surgery, and spinal cord compressionin patients with bone metastases.
Most patients living with such metastases have either breast or prostate cancer, but lung cancer as well as myeloma, renal cancer, and thyroid cancer frequently result in metastases in the bone.
Aredia (pamidronate disodium for injection, Novartis), used as an adjunct to standard anticancer therapy, is the only bisphosphonate now approved by the FDA for treating multiple myeloma or bone metastases from breast cancer. Zometa is used worldwide to treat hypercalcemia of malignancy, and the FDA approved the drug for that use in the United States on August 20, 2001.