Novartis files application with FDA for Zometa® in a broad range of cancer-related bone complications
Novartis announced today that it has submitted an application to the food and Drug Administration (FDA), seeking marketing authorization for Zometa® (zoledronic acid for injection) in the treatment of bone complications (metastases) associated with a broad range of tumor types. These include prostate and lung cancer, for which no bisphosphonate therapy is currently approved, as well as breast cancer and multiple myeloma. Bone metastases, or the spread of cancerous cells from the original tumor to the bone, can lead to serious complications called skeletal related events (SREs) [e.g., fractures, compression of the spinal cord, severe bone pain and hypercalcemia].
Zometa is a new generation intravenous bisphosphonate that was approved by the FDA just four days ago (20 August 2001) for the treatment of hypercalcemia of malignancy (HCM), the most common life-threatening metabolic complication of cancer. To date, Novartis has received marketing clearances for Zometa in the treatment of HCM in more than 30 countries, including the EU, Switzerland, Brazil, Canada and Australia. Novartis has filed a supplemental application in the EU for the treatment of bone metastases.
Today's submission for FDA review is based on data from three trials evaluating more than 3,000 patients. This is the largest set of clinical trials ever conducted to evaluate the efficacy and tolerability of bisphosphonates in treating bone metastases. The trials evaluated 4 mg of Zometa given as a 15-minute infusion every three or four weeks. In the prostate cancer trial, Zometa demonstrated clear 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 an SRE compared to those receiving placebo. Further, patients on Zometa had a delay in the onset of the first SRE when 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 these two well-controlled clinical trials mark the first time any bisphosphonate has demonstrated efficacy in treating SREs associated with prostate cancer, lung cancer and other solid tumors. In the third trial, in breast cancer and multiple myeloma, 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 the 2 to 24 hours for Aredia.
"Bone complications can be extremely debilitating to cancer patients, and seriously impact their day to day activities. Zometa offers these patients an effective treatment with a convenient 15-minute infusion time," said David Epstein, President, Novartis Oncology. "Novartis is pleased to bring forward another drug that will help make a marked difference in the lives of cancer patients and their families."
Bone Complications of Metastatic Cancer Bone metastases/lesions are a common complication in prostate, breast and lung cancer, and multiple myeloma patients, and can have severe debilitating consequences.
Current therapeutic options for complications of bone metastases include: chemotherapy, hormonal therapy, radiotherapy, analgesics for pain management, and surgery. While Aredia is approved for use in breast cancer patients with bone metastases and multiple myeloma patients with osteolytic lesions; it is not approved for use in bone metastases associated with prostate, lung cancer, and other solid tumors.
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