Millennium Pharmaceuticals has announced the FDA’s approval of bortezomib (Velcade), without dose adjustments, for use in patients with impaired kidney function, including patients who need dialysis. Impaired kidney function is a common complication related to multiple myeloma.
The label expansion is based on data from a prospective phase 1 trial. Bortezomib was approved in 2003.
The drug is being co-developed with Johnson & Johnson. For a limited period of time, Millennium and Ortho Biotech are co-promoting bortezomib in the U.S.
In the U.S., this product is indicated for patients with multiple myeloma who have received at least one prior therapy and for patients with mantle cell lymphoma who have received at least one prior therapy.
(Source: Millennium, October 15, 2007.)