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FDA Advisory Committee Recommends Approval of Zometa (Zoledronic Acid) for Bone Metastases EAST HANOVER, NJ -- February 1, 2002 -- Novartis announced today that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration recommended approval of Zometa® (zoledronic acid for injection) for the treatment of bone complications (metastases) associated with a broad range of tumor types. These include prostate cancer, lung cancer, and other tumor types for which no intravenous bisphosphonate therapy is currently approved for treatment, as well as breast cancer and the osteolytic lesions associated with multiple myeloma. Zometa offers patients and clinicians a highly effective treatment with a convenient 15-minute infusion time. The Food and Drug Administration (FDA) generally follows the recommendations of its Advisory Committees although it is not obliged to do so. Novartis submitted the new drug application (NDA) for the use of Zometa in these indications to the FDA on August 22, 2001. On October 23, 2001 the NDA received a priority review designation. Submission to the EMEA in the European Union was made on July 30, 2001. The NDA for Zometa is based on data from three large international clinical trials evaluating more than 3,000 patients with myeloma, breast cancer, prostate cancer, lung cancer and other solid tumors. This is the largest set of clinical trials ever conducted to evaluate the efficacy and tolerability of a bisphosphonate in treating cancerous bone lesions. In the prostate cancer trial, Zometa demonstrated efficacy when compared to placebo in the treatment of bone metastases. Over the 15-month evaluation period of this trial, a lower proportion of patients receiving Zometa experienced a skeletal related event (SRE), such as radiation to bone, pathological fractures, and spinal cord compression compared to those receiving placebo. Additionally, patients on Zometa had a delay in the onset of the first SRE compared to placebo. In the trial in lung cancer and other solid tumors (excluding breast and prostate cancer), Zometa had a positive impact on median time to the first SRE when compared to placebo. The results of the prostate cancer trial and the lung cancer and other solid tumor trial mark the first time any bisphosphonate has demonstrated efficacy in treating SREs. The FDA approval of Zometa for these indications would mark the first time a bisphosphonate would be available to this patient population. More than 250,000 patients worldwide suffer from bone complications from metastatic prostate cancer. In the breast cancer and multiple myeloma trial, Zometa was as effective and well tolerated as Aredia® (pamidronate disodium for injection) -- the current standard of treatment -- with the added convenience of a 15-minute infusion time versus two-to-four hours for Aredia. "Before Zometa, there was no bisphosphonate therapy available that was effective in all bone metastases regardless of metastatic origin. In particular, there was no effective therapy at all for patients affected with bone metastases resulting from prostate or lung cancer," said James Berenson, MD, Director, Myeloma & Bone Mets Program, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California. "The extensive data, combined with the convenient infusion time, suggest Zometa may become the new standard of treatment for these patients." Zometa is a new generation intravenous (IV) bisphosphonate. Novartis has previously received marketing clearance for Zometa in the treatment of hypercalcemia of malignancy (HCM), also known as tumor-induced hypercalcemia (TIH), in the European Union and more than 60 countries, including the United States, Switzerland, Brazil, Canada and Australia. In clinical trials in patients with bone metastases, Zometa was generally well tolerated with a safety profile similar to other bisphosphonates. The most commonly-reported adverse events included 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. Bisphosphonates, including Zometa, have been associated with reports of renal function deterioration. Patients who receive Zometa should have periodic evaluations of standard laboratory and clinical parameters of renal function. Doses of Zometa should not exceed 4 mg and the duration of infusion should be no less than 15 minutes. Zometa should only be used during pregnancy if the potential benefit justifies the risk to the fetus. Zometa is contraindicated in patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of Zometa. SOURCE: Novartis Oncology E-mail this page to a friend or colleague! To print, use this version