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Bortezomib Recommended for European Marketing Approval
The CPMP's opinion was issued today in London, U.K., and will be forwarded to the European Commission. The Company anticipates that the Commission will ratify the opinion and will issue a Marketing Authorization in the second quarter of this year. Under a Marketing Authorization, a single license would be granted to Millennium to market VELCADE (bortezomib) in the 15 member states of the European Union, the 10 accession member countries, plus Norway and Iceland.
"The Committee's positive recommendation to approve this application represents another significant step toward the Company's global mission of developing breakthrough products that make an important difference in patients' lives," said David Schenkein, M.D., vice president, oncology clinical development at Millennium. "With its new and unique mechanism of action of inhibiting the proteasome, VELCADE (bortezomib) is different from traditional chemotherapies and represents a completely new approach to treating cancer."
Under the terms of the co-development and commercialization agreement for VELCADE (bortezomib), Ortho Biotech and its affiliate, Janssen-Cilag, will commercialize VELCADE (bortezomib) outside of the U.S., including Europe. Millennium will receive royalties from Ortho Biotech and its affiliate Janssen-Cilag on sales outside the U.S.
"We are pleased to have worked in partnership with Millennium to secure a positive CPMP opinion for VELCADE (bortezomib) in Europe," said Martine George, M.D., vice president, global clinical research and development for Johnson & Johnson Pharmaceutical Research and Development, L.L.C. "We are committed to bringing this important medication forward to multiple myeloma patients in Europe as quickly as possible."
In the U.S., the drug was approved in May 2003 for patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Millennium continues to investigate the full potential of VELCADE (bortezomib) in both hematologic and solid tumors and currently has over 80 ongoing or planned clinical trials.
About VELCADE(R) (bortezomib) for Injection
VELCADE, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma -- a cancer of the blood. Millennium received approval from the U.S. Food and Drug Administration (FDA) on May 13, 2003 to market VELCADE for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit such as an improvement in survival.
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 will be responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. will be responsible for Japan.
VELCADE has a generally predictable, manageable safety profile (with appropriate monitoring and, if necessary, dose modification). VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
In 228 patients who were treated with VELCADE(R) (bortezomib) for Injection in two phase II studies of multiple myeloma, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (65 percent), nausea (64 percent), diarrhea (51 percent), appetite decreased (including anorexia) (43 percent), constipation (43 percent), thrombocytopenia (43 percent), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (37 percent), pyrexia (36 percent), vomiting (36 percent), and anemia (32 percent). Fourteen percent of patients experienced at least one episode of grade four toxicity, with the most common toxicity being thrombocytopenia (3 percent) and neutropenia (3 percent). A total of 113 (50 percent) of the 228 patients experienced serious adverse events (SAEs). The most commonly reported SAEs included pyrexia (7 percent), pneumonia (7 percent), diarrhea (6 percent), vomiting (5 percent), dehydration (5 percent) and nausea (4 percent).
For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-(866)-VELCADE.
Source: Millennium Pharmaceuticals, Inc.,