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Updated Label Issued for Zoledronic Acid To Include Long-Term Data

East Hanover, NJ, August 15, 2003 – The U.S. Food and Drug Administration (FDA) has issued an approvable letter, pending completion of labeling discussions, for the supplemental new drug application (sNDA) for ZOMETA® (zoledronic acid) Injection for patients with bone metastases from advanced cancers, Novartis announced today.

Novartis submitted the sNDA for the updated labeling on existing indications to the FDA in October 2002. The data upon which the application was filed provide clinicians long-term data (approximately two years) to advance their understanding of the role of ZOMETA in the treatment of cancer-related bone complications. Bone complications, also known as skeletal related events (SREs), include, among others, pathological fractures, a need for radiation or surgery to bone, spinal cord compression, and hypercalcemia.

“Nearly 500,000 patients worldwide have received Zometa to date, making it the most widely used bisphosphonate for the treatment of cancer-related bone complications,” said David Epstein, President, Novartis Oncology. “These data of up to 24 months, filed with the FDA, provide valuable insights on the broad utility and appropriate use of ZOMETA.”

An intravenous bisphosphonate, ZOMETA is the first therapy of its kind to demonstrate efficacy in treating bone complications across a broad range of tumor types such as breast, prostate, lung and renal cell cancers. Prior to ZOMETA, IV bisphosphonates had only been indicated for use in multiple myeloma and breast cancer patients with bone metastasis. ZOMETA offers patients, nurses and clinicians a convenient 4 mg, 15-minute infusion time.

ZOMETA was granted marketing authorization by the FDA in February 2002 for the treatment of bone complications in patients with advanced malignancies involving bone. This indication was based on data from three large pivotal trials of more than 3,000 patients that evaluated the drug for a treatment period of approximately one year.

ZOMETA is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. In prostate cancer, patients should have progressed after treatment with at least one hormonal therapy. The solid tumors studied included, among others, prostate, breast, lung, renal and colon. ZOMETA also is indicated for the treatment of hypercalcemia of malignancy (HCM), the most common life-threatening metabolic complication of cancer.

Contraindications and Adverse Events
In clinical studies, the safety profile with ZOMETA was similar to that of other intravenous bisphosphonates or placebo. ZOMETA and other IV 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 used in aspirin sensitive patients, or with aminoglycosides, loop diuretics, and other potentially nephrotoxic drugs. Due to the risk of clinically significant deterioration in renal function, single doses of ZOMETA should not exceed 4 mg and the duration of infusion should be no less than 15 minutes in 100 ml of dilutent.

In clinical trials in patients with bone metastases and hypercalcemia of malignancy (HCM), ZOMETA had a safety profile similar to other intravenous 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. 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

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