Key Data on VELCADE(R) (Bortezomib) for Injection in Front-Line Studies and Beyond at the International Multiple Myeloma Workshop
Friday April 8, 8:18 am ET
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- Over 20 presentations and posters, including results from multiple frontline studies --
CAMBRIDGE, Mass., April 8 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that positive results from studies of VELCADE®, an approved treatment for patients with multiple myeloma (MM) who have had at least one prior therapy, will be featured at the 10th Annual International Multiple Myeloma Workshop in Sydney, Australia, April 10-15, 2005. Highlights include:
* Front-line results from phase I/II studies of VELCADE alone or in
combination with dexamethasone; pegylated liposomal doxorubicin;
melphalan/prednisone; and dexamethasone/doxorubicin.
* Second-line results from a phase III multi-center trial comparing
VELCADE to high-dose dexamethasone, with clinical outcomes reported by
type of prior therapy.
* Results of phase I/II studies in relapsed and/or refractory patients
investigating VELCADE in combination with melphalan; dexamethasone,
pegylated liposomal doxorubicin/thalidomide, and lenalidomide, as well
as a single agent in high risk patients.
(Logo: newscom.com )
In addition, VELCADE will be the subject of the meeting's plenary session covering new therapeutic agents in MM, and a symposium exploring the role of proteasome inhibition in the changing MM treatment paradigm. Meeting information can be accessed at the official website myeloma2005.org and abstracts will be published in Haematologica, the journal of the European Hematology Association.
VELCADE is the only drug therapy to demonstrate a significant survival advantage when compared to standard treatment in relapsed MM. It is currently approved in more than 40 countries around the world.
About Multiple Myeloma (MM)
MM is the second most common blood cancer 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 United States, more than 40,000 individuals have MM and over 14,000 new cases of the disease are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths due to multiple myeloma each year.
About VELCADE® (bortezomib) for Injection
VELCADE is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension, cardiac disorders, gastrointestinal adverse events, thrombocytopenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.
In 331 patients who were treated with VELCADE 1.3 mg/m2 dose in the phase III APEX study, the most commonly reported adverse events were asthenic conditions (61%), diarrhea (57%), nausea (57%), constipation (42%), peripheral neuropathy (36%), vomiting (35%), pyrexia (35%), thrombocytopenia (35%), psychiatric disorders (35%) and anorexia and appetite decreased (34%). Fourteen percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4%), neutropenia (2%) and hypercalcemia (2%). A total of 144 patients on VELCADE (44%) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6%), diarrhea (5%), dyspnea and pneumonia (4%) and vomiting (3%).
VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for Japan.
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).
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, co- promotes INTEGRILIN® (eptifibatide) Injection, a market-leading cardiovascular product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in three therapeutic areas: oncology, cardiovascular, and inflammation. By applying its knowledge of the human genome, its understanding of disease mechanisms, and its industrialized drug discovery platform, the Company is seeking to develop breakthrough products. |
