Healthcare Industry News: liver failure
News Release - December 12, 2006
VELCADE(R) (bortezomib) for Injection Incorporated Into NCCN(R) Clinical Practice Guidelines for Newly Diagnosed Multiple MyelomaCAMBRIDGE, Mass., Dec. 12 (HSMN NewsFeed) -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM ) today announced that VELCADE® (bortezomib) for Injection, the only single agent to demonstrate a survival benefit in patients with relapsed multiple myeloma (MM), has been added to the updated National Comprehensive Cancer Network (NCCN) treatment protocol for newly diagnosed MM patients. These practice guidelines are a benchmark for clinical policy in the oncology community. The guidelines are updated continually in a process with explicit review of the evidence by multidisciplinary panels of expert physicians from NCCN member institutions. NCCN has posted the updated information to their website at http://www.nccn.org.
"A major addition to the guidance is the inclusion of bortezomib as front-line therapy for multiple myeloma, an addition based on data from 12 Phase II clinical trials in more than 600 patients," said Kenneth C. Anderson, M.D., Kraft Family Professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute and NCCN Multiple Myeloma Cancer Guidelines Panel Chair.
"The inclusion of VELCADE in the NCCN guidelines is critical to helping improve the outcomes of newly diagnosed patients," said Nancy Simonian, M.D., Senior Vice President and Chief Medical Officer, Millennium. "The complete response rates we've seen in emerging data thus far with VELCADE in the front-line multiple myeloma setting and our three, large, registration-enabling Phase III studies currently ongoing in this treatment setting, add to the growing data supporting VELCADE as the backbone of therapy in all lines of therapy."
VELCADE is approved by the Food and Drug Administration for the treatment of MM patients who have received at least one prior therapy. It is the market leader in the U.S. with over 50,000 patients treated worldwide and the only single agent with an unmatched median survival of 29.8 months in patients who have received one to three prior therapies. The Company, together with co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C., currently has three, large international Phase III trials underway evaluating VELCADE based combinations in newly diagnosed patients. Collectively, these studies are anticipated to enroll approximately 2,000 patients.
The NCCN guidelines are distributed free of charge to clinical professionals in the United States and internationally. User-friendly patient versions of NCCN guidelines are available to patients and their families. For more information, call the NCCN at (215) 690-0300 or visit http://www.nccn.org.
About Multiple Myeloma
MM is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and over 15,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.(1)
VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. will co-promote VELCADE in the U.S. VELCADE also is approved in the European Union after first relapse.
VELCADE is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. VELCADE is indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron or mannitol. VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension observed throughout therapy, cardiac and pulmonary disorders, gastrointestinal adverse events, thrombocytopenia, neutropenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE. Cases of severe sensory and motor peripheral neuropathy have been reported. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with few or no risk factors for decreased left ventricular ejection fraction. There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome (ARDS) in patients receiving VELCADE. Some of these events have been fatal. A higher proportion of these events have been reported in Japan. There have been rare reports of RPLS in patients receiving VELCADE. RPLS is a rare, reversible, neurological disorder which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. VELCADE is associated with thrombocytopenia and neutropenia. There have been reports of gastrointestinal and intracerebral hemorrhage in association with VELCADE. Transfusions may be considered. Complete blood counts (CBC) should be frequently monitored during treatment with VELCADE. Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.
Safety Data: In 1163 patients in MM and MCL studies, the most commonly reported adverse events were asthenic conditions (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy (39%), thrombocytopenia (36%), appetite decreased, including reports of anorexia (36%), pyrexia (34%), vomiting (33%) and anemia (29%). Twenty percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (5%) and neutropenia (3%). Fifty percent of patients reported serious adverse events (SAEs). The most commonly reported SAEs were pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in two therapeutic areas: oncology and inflammation. By applying its knowledge of the human genome, understanding of disease mechanisms and industrialized drug discovery platform, Millennium is developing an exciting pipeline of innovative product candidates. The Company's website is http://www.millennium.com.
This press release contains "forward-looking statements," including statements about the Company's growth and development of products. Various important risks may cause the Company's actual results to differ materially from the results indicated by these forward-looking statements, including: adverse results in its drug discovery and clinical development programs; failure to obtain patent protection for its discoveries; commercial limitations imposed by patents owned or controlled by third parties; the Company's dependence upon strategic alliance partners to develop and commercialize products and services based on its work; difficulties or delays in obtaining regulatory approvals to market products and services resulting from its development efforts; product withdrawals; competitive factors; difficulties or delays in manufacturing the Company's products; government and third party reimbursement rates; the commercial success of VELCADE and INTEGRILIN® (eptifibatide) Injection; achieving revenue consistent with internal forecasts; and the requirement for substantial funding to conduct research and development and to expand commercialization activities. For a further list and description of the risks and uncertainties the Company faces, see the reports it has filed with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Editors' Note: This press release is also available under the Media section of the Company's website at: http://www.millennium.com.
1. American Cancer Society, Overview: Multiple Myeloma, 2005, http://www.cancer.org
Source: Millennium Pharmaceuticals
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