Imaginis - New Drug Zometa Treats Complication of Breast Cancer, Seeking FDA Approval for Breast Cancer That Has Spread to Bone

Advertisement


	New Drug Zometa Treats Complication of Breast Cancer, Seeking FDA Approval for Breast Cancer That Has Spread to Bone (dateline August 28, 2001)	Format for Printing

	The drug Zometa (brand name, zoledronic acid) recently received approval by the U.S. Food and Drug Administration (FDA) to treat elevated calcium levels (hypercalcemia of malignancy, HCM). HCM is a complication that can occur in cancer patients, including those with advanced breast cancer whose cancer has spread past the breast and lymph nodes to the bone. The FDA is also considering approving market authorization of Zometa to treat bone metastases (cancer that has spread to the bone) in patients with breast cancer and other cancers. Clinical trials of Zometa show that it may be more effective than the drug Aredia, the standard treatment for bone metastases. When breast cancer spreads past the breast and axillary (armpit) lymph nodes, it often spreads first to the bone. These breast cancer tumors in the bone are called "bone metastases." As advanced breast cancer dissolves portions of bone, a variety of problems can occur. Bone metastases can cause pain, decreased physical activity, and potentially severe problems such as fractures. Other complications that can arise from bone metastases include the surgical treatment for fractures, HCM, and spinal cord compression (vertebral damage due to pressure on the spinal cord). Zometa belongs to a class of drugs called bisphosphonates and has shown promise in treating complications from bone metastases. In particular, Zometa has received FDA approval to treat HCM, a condition that affects approximately 10% of cancer patients. HCM results when cancer cells over-stimulate bone-destroying cells called osteoclasts. In turn, the osteoclasts accelerate the breakdown of bone, which contributes to abnormally high levels of calcium in the blood that can overload the kidneys. HCM most often occurs in patients with breast cancer, lung cancer, and multiple myeloma (a type of blood cancer). Early diagnosis and treatment of HCM greatly improves the chances of survival. In clinical trials prior to FDA approval, Zometa was shown to correct high calcium levels associated with HCM faster than Aredia, another drug used to treat HCM. Patients who were given Zometa also experienced longer periods before relapse than those who received Aredia (30 days for Zometa versus 17 days for Aredia). Zometa can be given during a 15-minute infusion time versus an infusion time of two to 24 hours that is necessary with Aredia. In addition to treating high calcium levels (HCM), Zometa may soon be available as a treatment for several cancers that have spread to the bone, including breast, prostate, lung, and multiple myeloma. Data from three clinical trials involving more than 3,000 patients have shown that Zometa is effective at preventing or delaying complications such as bone fractures, compression of the spinal cord, and severe bone pain. Aredia is currently used to treat bone metastases in patients with breast cancer or multiple myeloma. However, it is not FDA approved for use in patients with cancers of the prostate, lung, or other solid tumors. Both Zometa and Aredia are manufactured by Novartis. Possible side effects of Zometa for HCM may include: Fever Chills Bone pain Muscle or joint pain (myalgia/arthralygia) Nausea or vomiting According to an expert panel of the American Society of Clinical Oncology (ASCO), bisphosphonates (such as Zometa and Aredia) have shown benefits in reducing bone complications. However, bisphosphonates have not had an impact on patient survival (i.e., advanced cancer patients do not live longer if they take bisphosphonates). Thus, bisphosphonates are used to improve a patient’s quality of life rather than cure the disease. While bisphosphonates can be helpful, the ASCO believes they should not replace current standards of treatment for cancer pain due to bone metastases, such as local radiation therapy and other medications. Additional Resources and References The August 24, 2001 Novartis news release, "Novartis Files Application with FDA for Zometa in a Broad Range of Cancer-Related Bone Complications," is available at http://www.novartis.com The August 21, 2001 Novartis news release, "FDA Approves Novartis’ Zometa for the Treatment of Hypercalcemia of Malignancy," is available at http://www.novartis.com The study, " Zoledronic Acid is Superior to Pamidronate in the Treatment of Hypercalcemia of Malignancy: A Pooled Analysis of Two Randomized, Controlled Clinical Trials," is published in the January 2001 issue of the Journal of Clinical Oncology. The full report is available online to journal subscribers and an abstract of the report is available to non-subscribers at http://www.jco.org/ Novartis provides information on Zometa at http://www.zometa.com and Aredia at http://www.aredia.net/ The August 21, 2001 Imaginis report, "Scientists Investigate Treatments for Breast Cancer That Has Spread to the Bone," is available at http://www.imaginis.com/breasthealth/news/news8.21.01.asp To learn more about Aredia, please visit http://www.imaginis.com/breasthealth/bc_drugs.asp#Aredia To learn more about advanced/metastatic breast cancer, please visit http://www.imaginis.com/breasthealth/metastatic.asp Return to Breast Health News Archives

Imaginis.com subscribes to the HONcode principles of the Health on the Net Foundation.

Copyright © 1997-2008 Imaginis Corporation. All rights reserved. Imaginis® is a registered service mark of Imaginis Corporation, a health services company. All other trademarks and copyrights are property of their respective owners. Note: Use of this online service is subject to the disclaimer and the terms and conditions contained herein. Information found within the Imaginis.com website or in other sites linked to from Imaginis.com is provided for educational purposes only and is not intended to be used as a substitute for diagnosis and treatment by a medical doctor. Imaginis does not endorse and has no responsibility for the content of any other sites listed on Imaginis.com, and provides links and references merely as a convenience to its users. Seek immediate medical attention if your condition is urgent.