FDA Approves Zoledronic Acid for Cancer-Related Bone Complications

April 1, 2002

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.

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

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

Three Large Trials

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

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

Unmet Clinical Need

"Advanced cancers commonly spread to bone and cause avariety of complications that can significantly impact a patient’s day-to-dayactivities," said Matthew Smith, MD, PhD, assistant professor of medicineat 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 importantaddition to the current standard treatments for men with advanced prostatecancer."

Safety Considerations

Zoledronic acid and other bisphosphonates have been associatedwith renal insufficiency. Patients should have serum creatinine levels assessedprior to receiving each dose of zoledronic acid. Caution is advised whenadministering zoledronic acid with other potentially nephrotoxic drugs. Doses ofthe agent should not exceed 4 mg, and the duration of infusion should be no lessthan 15 minutes.

Zoledronic acid was generally well tolerated, with a safetyprofile similar to that of other bisphosphonates. The most commonly reportedadverse 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 mineraldisturbances, such as low serum phosphate, calcium, magnesium, and potassium.