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| |  Aredia is cleared for marketing by FDA for use in Multiple Myeloma EMERYVILLE, Calif., September 4, 1995 -- Chiron Corporation (NASDAQ:CHIR) and Ciba Pharmaceuticals jointly announced today that the United States Food and Drug Administration (FDA) has cleared for marketing Aredia (pamidronate disodium for injection) as the first drug for the treatment of patients with osteolytic bone lesions of multiple myeloma, a malignancy of plasma cells in the bone marrow, in conjunction with standard anti-myeloma chemotherapy. Aredia is developed and manufactured by Ciba and marketed exclusively in the United States by the Chiron Therapeutics business unit of Chiron. The approval is based on the results of a large-scale clinical trial, sponsored by Ciba, demonstrating that Aredia is well-tolerated and effective in reducing skeletal complications such as skeletal fractures, bone pain and elevated calcium levels in multiple myeloma patients with osteolytic bone lesions. Aredia was first cleared for marketing in 1991 for treatment of moderate or severe hypercalcemia of malignancy with or without bone metastases, and in 1994 was cleared for marketing for treatment of moderate-to-severe Paget's disease, a metabolic bone disorder. Multiple myeloma is a cancer characterized by the proliferation of malignant plasma cells in the bone marrow which, in more than two-thirds of patients, results in skeletal complications due to progressive and irreversible bone destruction. In the United States, there are an estimated 50,000 people living with multiple myeloma and approximately 13,000 newly diagnosed cases of multiple myeloma each year. Their treatments prior to Aredia have been limited to radiotherapy, narcotics, chemotherapy and surgery. Osteolytic bone destruction is a common characteristic of multiple myeloma. Bone destruction in multiple myeloma results from the release of soluble factors by myeloma cells that activate osteoclasts to resorb bone. These bone changes can cause severe bone pain and pathologic fractures and may lead to spinal cord compression or collapse resulting in significant neurologic complications. In a multi-center, double-blind, placebo-controlled Phase 3 clinical trial, Aredia was studied in 377 evaluable patients with Stage III multiple myeloma and one or more lytic lesions. Patients were randomized to receive either 90 mg of Aredia (196 patients) or placebo (181 patients) for nine months as a monthly four-hour intravenous infusion in addition to their anti-myeloma regimen. The study was stratified according to whether patients were receiving first-line or second-line chemotherapy. The study demonstrated that 41 percent of patients receiving placebo developed a skeletal complication (fractures, local irradiation, spinal compression, and/or surgery) compared to 24 percent in the Aredia arm (P less than .001). Moreover, fewer patients receiving Aredia suffered any pathologic fracture (P=.004) or needed any radiation to bone (P=.049). Aredia-treated patients receiving therapy as soon as lytic lesions appeared as well as later during the course of disease had a significant benefit from use of the drug. In addition, decreases in pain scores from baseline occurred at endpoint for those Aredia-treated patients with pain at baseline (P=.026). At endpoint, a worsening from baseline was observed in the placebo group for the Spitzer quality of life variable (P less than .05) and ECOG performance status (P less than .011) while there was no significant deterioration from baseline in these parameters in patients treated with Aredia. There was no difference in response to chemotherapy between the two arms of the study. Aredia is effective and well-tolerated. The most commonly reported adverse experiences in multiple myeloma patients treated with Aredia were mild, transient fever, arthralgia, bone pain, infusion site reaction, asymptomatic hypomagnesia, asymptomatic hypokalemia and asymptomatic hypocalcemia. Rare cases of symptomatic hypocalcemia (including tetany) also have been reported. Aredia should not be used to treat patients with clinically significant hypersensitivity to Aredia or other bisphophanates. "These clinical results represent a significant advancement for the treatment of multiple myeloma and management of its complications," said James R. Berenson, M.D., associate professor of medicine, UCLA School of Medicine and chief of medical oncology, DVA West Los Angeles and principal investigator of the trial. "Bone complications are a serious aspect of multiple myeloma. For the first time, with Aredia, physicians will be able to provide multiple myeloma patients with a drug that reduces the incidence of pathologic fractures, necessity for radiation therapy, relieves bone pain and substantially preserves the quality of their lives." Aredia is believed to work by inhibiting bone resorption without inhibiting bone formation and mineralization. "This new indication for Aredia was cleared six months after our regulatory submission, which demonstrates the commitment of the FDA to act quickly on behalf of patients to provide access to drugs that can induce significant benefits," said Dr. John Seaman, director of clinical development at Ciba Pharmaceuticals, the drug's developer. "We thank the cooperative efforts of the clinical investigators and patients who participated in the study, and those at the agency who made this rapid review possible." "Aredia has proven to be a successful therapy in its current indications, Paget's disease of bone and hypercalcemia of malignancy," noted Edward Kenney, vice president of sales and marketing, Chiron Therapeutics. "The clear-cut results of the multiple myeloma trial indicate that Aredia also will be successful in this new indication. Bone destruction in myeloma is responsible for the most distressing clinical features of the disease. Bone complications associated with multiple myeloma are progressive and irreversible, and may persist even when patients are responding to chemotherapy. The benefits demonstrated by Aredia provide the basis for the early initiation and continued use of Aredia in conjunction with standard anti-myeloma therapy, and represent a major advance in improving the quality of life for patients whose options in the past were limited. Aredia is an important part of the Chiron Therapeutics oncology product line, which includes our flagship product Proleukin and an expanding line of cancer chemotherapeutics." Chiron Therapeutics is a business unit of Chiron which, in addition to Aredia, markets Proleukin (aldesleukin), the first treatment for metastatic renal cell carcinoma, in the United States and Europe. In the United States, Chiron Therapeutics also markets a line of generic cancer chemotherapeutics in a joint venture with Ben-Venue Laboratories of Cleveland, Ohio. For more information about Aredia for multiple myeloma, please call Chiron's Professional Services group at 1-800/CHIRON-8, selection no. 2. Ciba Pharmaceuticals Pharmaceuticals is a division of Ciba-Geigy Corporation of Tarrytown, N.Y., a wholly owned subsidiary of Ciba-Geigy Limited of Basel, Switzerland. Ciba is a leading developer and manufacturer of healthcare and agricultural products and specialty chemicals for industry. Ciba Pharmaceuticals is dedicated to discovering, developing, manufacturing and marketing innovative pharmaceuticals that meet unmet medical needs and improve patients' quality of life. Chiron Corporation is a diversified, science-driven healthcare company that combines diagnostic, vaccine and therapeutic strategies for managing disease. Chiron participates in four global healthcare markets: diagnostics, including immunodiagnostics, critical care diagnostics and new quantitative probe tests; therapeutics, with an emphasis on oncology and infectious disease; pediatric and adult vaccines; and ophthalmic surgical products for the correction of vision. A fifth business, Chiron Technologies, manages programs in gene therapy and combinatorial chemistry.
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