Timelines: 2003
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Velcade®
A proteasome inhibitor against multiple myeloma
Millennium Pharmaceuticals receives permission from the FDA to market the injectable drug Velcade® (bortezomib) for the treatment of patients with relapsed multiple myeloma, a cancer of the blood. Velcade® is a proteasome inhibitor. Proteasomes are protein complexes that clean up cellular debris. They break down excess and damaged proteins that can interfere with healthy cellular functioning. Velcade® prevents proteasomes from doing this job, and, as a result, cells – including cancerous myeloma cells – stop growing and die. It is the first new treatment for multiple myeloma to be approved in over a decade.
In December 2007, Millennium submits a supplemental application for regulatory approval of Velcade® as a front-line therapy for multiple myeloma. In June, after a priority review lasting just six months, the FDA grants the request and authorizes prescription of the drug for patients with untreated cancers. One month, Millennium is acquired by the Japanese drug corporation, Takeda Pharmaceutical Company, Ltd., for $8.8 million. Velcade® was developed in partnership with Ortho Biotech and Janssen-Silag, subsidiaries of Johnson & Johnson. Millennium and Takeda market the drug in the U.S., the Johnson & Johnson units are responsible for commercialization in Europe and the rest of the world.