= Zometa zoledronic acid (a bisphosphonate) receives FDA approval for drug use in bone problems of cancer, including prostate cancer and multiple myeloma patients - Multiple Myeloma patients. Article posted February 2002
February 26, 2002: Source: Novartis.
The FDA has approved Novartis Zometa = zoledronic acid to be used as supplementary drug in prostate cancer patients and bone problems of such Kahler - Multiple Myeloma patients. Whether or not this includes breast cancer patients is unclear to us. Here an article about this FDA approval for Zometa - zoledronic acid, bisphosphonate
FDA Approves Zometa (zoledronic acid) for Treatment of Cancer-Related Bone Complications BASEL, SWITZERLAND - February 25, 2002 - The U.S. Food and Drug Administration (FDA) today approved the Novartis drug Zometa ® (zoledronic acid) for the treatment of Patients with multiple myeloma and patients with bone metastases from solid tumors Documented in Conjunction with standard antineoplastic therapy. These solid tumors include prostate cancer, lung cancer, breast cancer and Other solid tumor types. In prostate cancer, patiënten Should have progressed after treatment with at least one Hormonal therapy. That the trials led to the approval of Zometa bisphosphonates Any marks the first time demonstrated efficacy in treating bone HAS Complications in Patients with prostate cancer, lung cancer and Other solid tumors. Further, Zometa sacrifices patient, nurses and clinicians a convenient 4 mg, 15-minute infusion time. "At Novartis we are committed to innovative and practical Developing new treatments for Patient with cancer," said David Epstein, President, Novartis Oncology. "With this approval, Zometa offerings 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 the NDA on 23 October 2001 Received a priority review designation. Submission to the EMEA in the European Union was made on 30 July 2001. The approval for Zometa clinical data is based on data from three large international clinical trial Evaluating More Than 3000 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 bisphosphonates 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 trials in patients with bone metastases from prostate cancer or solid tumors from Other, 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 can-cancerous bone lesions 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 communications cancers only spread to bone and cause a variety of can-Complications That significantly impacts 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 theses Complications, Especially in patient with prostate cancer, Zometa Which makes an important addition under to the current standard treatments for men with advanced prostate cancer." About Zometa Zometa is a new generation intravenous (IV) bisphosphonates. 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, s 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. Should not Exceed Doses of Zometa 4 mg and the duration of infusion Should Be no less Than 15 minutes. In clinical trials in patient with bone metastases, Zometa had Generally well tolerated, with a safety profile similar to Other bisphosphonates. The only musts comm Reported adverse events included flu-like syndrome (fever, arthralgias, myalgias, skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness, cough, dyspnea and edema. Occasionally, electrolyte and mineral disturbances Experienced Patients, Such As low serum phosphate, calcium, magnesium and potassium. Zometa Should not be Used consistently pregnancy. Zometa iscontraindicated in Patients with Clinically significant hypersensitivity to zoledronic acid or bisphosphonates Other, or Any of the excipients in the formulation of Zometa. SOURCE: Novartis AG
