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Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Oncology

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Zometa (zoledronic acid)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Novartis
Approval Status: Approved February 2002
Treatment Area: Multiple myeloma; bone metastases from solid tumors

General Information

Zometa has been approved for the treatment of multiple myeloma and for patients with bone metastases from solid tumors. For prostate cancer, which is included in this approval, patients should have progressed after treatment with at least one hormonal therapy. The drug is indicated for use in conjunction with standard antineoplastic therapy.

Zometa is a bisphosphonate that works by inhibiting the breakdown of bone (resorption). The drug was originally approved in August 2001 for the treatment of hypercalcemia of malignancy, a common life-threatening metabolic complication associated with cancer.

Clinical Results

The safety and effectiveness of Zometa was supported by three large international trials that included more than 3,000 subjects with multiple myeloma, breast cancer, prostate cancer, lung cancer and other solid tumors. The three trials consisted of a pamidronate-controlled trial in breast cancer and multiple myeloma, a placebo-controlled trial in prostate cancer, and a placebo-controlled trial in other solid tumors. Results demonstrated that Zometa decreased skeletal complications of subjects with multiple myeloma or metastases from solid tumors. In the two placebo-controlled trials, the number of subjects with skeletal events and the time to first skeletal-related event were both decreased compared to placebo.

Side Effects

Zometa, like other bisphosphonates, has been associated with renal insufficiency.

Adverse events reported in clinical trials with Zometa include (but are not limited to) the following:

  • Arthralgia (joint pain)
  • Myalgia (muscle pain)
  • Fatigue
  • Gastrointestinal reactions
  • Anemia
  • Weakness
  • Cough
  • Dyspnea (difficult or labored breathing)
  • Edema

Mechanism of Action

The principal pharmacologic action of zoledronic acid is inhibition of bone resorption. Although the antiresorptive mechanism is not completely understood, several factors are thought to contribute to this action. In vitro, zoledronic acid inhibits osteoclastic activity and induces osteoclast apoptosis. Zoledronic acid also blocks the osteoclastic resorption of mineralized bone and cartilage through its binding to bone. Zoledronic acid inhibits the increased osteoclastic activity and skeletal calcium release induced by various stimulatory factors released by tumors. (from Zometa Prescribing Information)

Additional Information

For more information on Zometa, please visit the product web site at www.zometa.com.

Additionally, a wide variety of cancer information can be obtained through the National Cancer Institute.