If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ASCO: Zometa (Zoledronic Acid) More Effective Than Pamidronate in Hypercalcemia of Malignancy EAST HANOVER, NJ -- May 23, 2000 -- New clinical findings presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans show a statistically significant higher percentage of cancer patients responded to the investigational agent Zometa™ (zoledronic acid for injection), in development for hypercalcemia of malignancy (HCM), compared to pamidronate, the current standard of treatment. In addition, Zometa, an intravenous bisphosphonate, and pamidronate were shown to have similar safety profiles. "These data strongly suggest Zometa is more effective than the current treatment in managing hypercalcemia of malignancy," said Pierre P. Major, MD, FRCPC, medical oncologist, Hamilton Regional Cancer Centre, Associate Professor, Department of Medicine, McMaster University, Hamilton, Ontario, Canada, and lead investigator of the studies. "HCM is the most common life-threatening metabolic complication associated with cancer, and these findings suggest Zometa may replace pamidronate as the standard of care for these patients." HCM is characterized by excess calcium in the bloodstream and may develop after a tumor has spread to the bone (bone metastases). Also known as tumor-induced hypercalcemia (TIH), HCM can occur with many tumor types but is associated more frequently with non small-cell lung cancer, breast cancer, and multiple myeloma. It affects upwards of 10 percent of all cancer patients. Pooled data from the two multi-center trials (275 patients met evaluation criteria out of a total 287 patients included in the studies) compared patients receiving a single dose of either Zometa 4 mg or Zometa 8 mg infused over five minutes, to patients receiving a single dose of pamidronate 90 mg infused over two hours. By day 10 of treatment, corrected serum calcium concentrations were normalized in 88.4 percent of patients treated with Zometa 4 mg, and 86.7 percent treated with Zometa 8 mg. In comparison, only 69.7 percent of patients treated with pamidronate 90 mg achieved normalized serum calcium concentrations. Additionally, the median duration of complete response (maintaining normalized calcium levels) was higher in patients treated with Zometa than pamidronate (32 and 43 days for Zometa 4 and 8 mg, and 18 days for pamidronate 90 mg). The most commonly reported adverse events did not significantly differ among the three treatment groups. Adverse events, not necessarily related to drug administration, included fever, progression of the underlying cancer, anemia, nausea, constipation, and dyspnea. HCM most often occurs in advanced cancer and is caused by the tumor-related activity of bone cells known as osteoclasts. In normal circumstances, bones break down and re-form themselves in a continuous, balanced process. However, in HCM, osteoclasts accelerate bone breakdown (resorption) and release excess calcium into the bloodstream. Because the kidneys cannot process the calcium overload, HCM usually leads to severe dehydration and can cause death. Therefore, early diagnosis and treatment can be immediately lifesaving, while long-term treatment might enable the patient to complete cancer therapy. Zometa normalizes dangerously elevated levels of calcium serum in HCM by inhibiting the abnormal activity of osteoclasts. Zometa has been designated for priority review by the U.S. Food and Drug Administration (FDA). An FDA decision is expected in June on the marketing clearance of Zometa for the treatment of hypercalcemia of malignancy. Products represented by the Novartis oncology franchise include Aredia® (pamidronate disodium for injection) for the treatment of osteolytic bone metastases in patients with multiple myeloma or breast cancer in conjunction with standard antineoplastic therapy, hypercalcemia of malignancy, and Paget's disease; Femara® (letrozole tablets) for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy; and Sandostatin LAR® Depot (octreotide acetate for injectable suspension) and Sandostatin® (octreotide acetate injection) for control of symptoms in patients with metastatic carcinoid and vasoactive intestinal peptide-secreting tumors (VIPomas), and for the treatment of acromegaly. In addition, a product to address hematologic disorders is managed by this group. Sandoglobulin® (Immune Globulin Intravenous (Human) [IGIV] is indicated for the maintenance therapy for primary immunodeficiency syndromes and for the treatment of immune thrombocytopenic purpura. Novartis also is investigating an agent for overcoming multidrug resistance in certain malignancies. Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group (including Agribusiness) achieved sales of USD 21.7 billion and invested more than USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,400 people and operates in over 140 countries around the world. The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000. Related Link: Novartis Pharmaceuticals Corporation.
|
