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FDA Approves Zoledronic Acid for Cancer-Related Bone Complications

FDA Approves Zoledronic Acid for Cancer-Related Bone Complications

The US Food and Drug Administration (FDA) has approved zoledronic acid (Zometa) for the treatment of bone complications in patients with multiple myeloma and patients with solid tumors, in conjunction with standard antineoplastic therapy. These solid tumors include prostate cancer, lung cancer, and breast cancer. Prostate cancer patients should have progressed after completing treatment with at least one hormonal therapy.

"At Novartis, we are committed to developing innovative and practical new treatments for patients with cancer," said David Epstein, president, Novartis Oncology. "With this approval, Zometa offers to physicians and patients a new, broadly effective and convenient treatment for the debilitating bone complications of cancer."

Three Large Trials

The approval of zoledronic acid is based on data from three large international clinical investigations that evaluated more than 3,000 patients with prostate cancer, lung cancer, breast cancer, other solid tumors, and multiple myeloma. These clinical trials demonstrated that zoledronic acid decreases the skeletal complications in patients with multiple myeloma and with metastases from solid tumors.

In two placebo-controlled clinical studies conducted in patients with bone metastases from prostate cancer or from other solid tumors, the number of patients with skeletal events decreased and the time to first skeletal-related event increased with zoledronic acid treatment, in comparison with placebo.

Unmet Clinical Need

"Advanced cancers commonly spread to bone and cause a variety of complications that can significantly impact a patient’s day-to-day activities," said Matthew Smith, MD, PhD, assistant professor of medicine at Harvard Medical School and Massachusetts General Hospital, Boston. "There’s an unmet clinical need to address these complications, especially in patients with prostate cancer, which makes Zometa an important addition to the current standard treatments for men with advanced prostate cancer."

Safety Considerations

Zoledronic acid and other bisphosphonates have been associated with renal insufficiency. Patients should have serum creatinine levels assessed prior to receiving each dose of zoledronic acid. Caution is advised when administering zoledronic acid with other potentially nephrotoxic drugs. Doses of the agent should not exceed 4 mg, and the duration of infusion should be no less than 15 minutes.

Zoledronic acid was generally well tolerated, with a safety profile similar to that of other bisphosphonates. The most commonly reported adverse events included a flu-like syndrome (fever, arthralgias, myalgias, skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness, cough, dyspnea, and edema. Occasionally, patients experienced electrolyte and mineral disturbances, such as low serum phosphate, calcium, magnesium, and potassium.

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