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ODAC Recommends That FDA Approve Zometa for Bone Metastases

ODAC Recommends That FDA Approve Zometa for Bone Metastases

ROCKVILLE, Maryland—Members 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 compression—in 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.

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