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| |  FDA Grants Priority Review For Zometa (Zoledronic Acid) For Treatment Of Bone Metastases EAST HANOVER, NJ -- October 23, 2001 -- Novartis announced today that Zometa® (zoledronic acid for injection) has been designated a priority review by the U.S. Food and Drug Administration (FDA) in the treatment of bone complications (metastases) associated with a broad range of tumor types. These included patients with prostate cancer, lung cancer, and other tumor types for which no intravenous bisphosphonate therapy is currently approved for treatment, as well as patients with breast cancer and multiple myeloma. The FDA grants priority review for therapies that may offer a significant improvement over available treatments. Novartis submitted the new drug application (NDA) for the use of Zometa to the U.S. FDA on August 22, 2001. Submission to the EMEA in the European Union was made on July 30, 2001. "Novartis is pleased that the FDA acknowledges the potential benefit Zometa has in treating bone metastases associated with a broad range of cancers," said David Epstein, President, Novartis Oncology. "Novartis continues to work with the FDA to ensure Zometa is thoroughly evaluated in the most timely manner possible." This application 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. Bone metastases/lesions are common complications in prostate, breast and lung cancer, and multiple myeloma patients, often with severe debilitating consequences. Novartis has previously received marketing clearance for Zometa in the treatment of tumor-induced hypercalcemia (TIH), also known as hypercalcemia of malignancy (HCM), in more than 40 countries, including the European Union (EU), United States, Switzerland, Brazil, Canada and Australia. In clinical trials in patients with bone metastases, adverse reactions to Zometa have usually been mild and transient and similar to those reported for other bisphosphonates. The most commonly associated 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. Limited clinical data are available regarding use of Zometa in patients with renal impairment. Early experience with Zometa in the clinical trials treating patients with bone metastases indicated that risk for renal function deterioration (defined as an increase in serum creatinine) is increased in patients who receive the drug over five minutes vs. 15 minutes. In addition, the risk for renal function deterioration is increased in patients receiving the 8 mg dose of Zometa, even over 15 minutes. 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 be used with caution in patients with aspirin-sensitive asthma. Caution should also be exercised when Zometa is used in combination with loop diuretics due to an increased risk of hypocalcemia. 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. In the bone metastases trials submitted for FDA review, Zometa was well tolerated and had comparable safety to that of Aredia in multiple myeloma and in breast cancer. In studies evaluating Zometa for treatment of bone metastases in prostate and lung cancer, Zometa had an acceptable safety profile.
SOURCE: Novartis Related Link: Novartis.
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