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Title: FDA Approves Zometa (Zoledronic Acid) for Treatment of Cancer-Related Bone Complications

"FDA Approves Zometa (Zoledronic Acid) for Treatment of Cancer-Related Bone Complications"

BASEL, SWITZERLAND -- February 25, 2002 -- The US Food and Drug Administration (FDA) today approved the Novartis drug Zometa® (zoledronic acid) for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. These solid tumors include prostate cancer, lung cancer, breast cancer and other solid tumor types. In prostate cancer, patients should have progressed after treatment with at least one hormonal therapy. The trials that led to the approval of Zometa mark the first time any bisphosphonate has demonstrated efficacy in treating bone complications in patients with prostate cancer, lung cancer and other solid tumors. Further, Zometa offers patients, nurses and clinicians a convenient 4 mg, 15-minute infusion time. "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." Novartis submitted the new drug application (NDA) for the use of Zometa in the bone metastases indication to the FDA on 22 August 2001 and on 23 October 2001 the NDA received a priority review designation. Submission to the EMEA in the European Union was made on 30 July 2001. Clinical data The approval for Zometa is based on data from three large international clinical trials evaluating more than 3,000 patients with prostate cancer, lung cancer and other solid tumors, breast cancer and multiple myeloma. This is the largest set of clinical trials ever conducted to evaluate the efficacy and tolerability of a bisphosphonate in treating the complications associated with cancerous bone lesions. Clinical trials demonstrated that zoledronic acid decreases the skeletal complications of patients with multiple myeloma and of patients with metastases from solid tumors. In two placebo-controlled clinical studies in patients with bone metastases from prostate cancer or from other solid tumors, both the number of patients with skeletal events and the time to first skeletal related event were decreased relative to placebo. Breast cancer, lung cancer, prostate cancer, and many other types of solid tumors often spread (metastasize) to bones, while multiple myeloma is a type of cancer that starts in bones. These cancerous bone lesions can cause a variety of complications that seriously affect a patient's life, such as pain, fractures, and/or a need for surgery or radiation therapy. "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, Harvard Medical School, Massachusetts General Hospital. "There is 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." About Zometa Zometa is a new generation intravenous (IV) bisphosphonate. Novartis initially 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. Contraindications and adverse events Zometa, and other bisphosphonates, have been associated with reports of renal insufficiency. Patients should have serum creatinine assessed prior to receiving each dose of Zometa. Caution is advised when Zometa is administered with other potentially nephrotoxic drugs. Doses of Zometa should not exceed 4 mg and the duration of infusion should be no less than 15 minutes. 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, dyspnoea and edema. Occasionally, patients experienced electrolyte and mineral disturbances, such as low serum phosphate, calcium, magnesium and potassium. Zometa should not be used during pregnancy. 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 AG

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