HIGH WYCOMBE, UK, 28th April 2005 Ortho Biotech, the biopharmaceutical division of Janssen-Cilag, today announced that the European Commission has approved the use of VELCADE (bortezomib) for Injection as a second-line treatment in patients with multiple myeloma. It is indicated as monotherapy for use in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation. With today's announcement, more multiple myeloma patients can hope to receive earlier access to VELCADE treatment. This decision formally ratifies the Committee for Human Medicinal Product Opinion made on 16th March 2005.
VELCADE received U.S. Food and Drug Administration (FDA) approval for second-line use in multiple myeloma in March of this year. It is indicated in the U.S. for patients who have received at least one prior line of therapy.
Multiple myeloma is the second most common blood cancer, representing approximately one percent of all cancers and two percent of all cancer deaths.(ref 1) In 2002 there were approximately 85,700 cases of multiple myeloma worldwide, with over 26,000 of these cases occurring in the EU.(ref 2) Only 30 percent of multiple myeloma patients survive longer than five years.(ref 3) More than 18,000 people in the EU die each year from the disease. (ref 2)
Professor Jesus San Miguel, Professor of Medicine at the University Hospital in Salamanca, Spain, commented, "The results we've seen in patients who have received VELCADE as the backbone at an earlier stage in the treatment cycle have been highly promising."
VELCADE offers a completely novel approach to treating multiple myeloma by acting on a unique target in cells called the proteasome. First approved in Europe on 26th April 2004 for the treatment of multiple myeloma patients who had received at least two prior therapies, VELCADE was the first treatment in more than a decade to be approved for this group of patients.
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Contact: Monica Shuman
monica_shuman@uk.bm.com
44-20-7300-6281
Burson-Marsteller
28-Apr-2005
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