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FDA expands label for bortezomib (Velcade) for patients with impaired kidney function.
Following submission of results from a phase I pharmacokinetics trial in patients with kidney impairment, Millennium Pharmaceuticals has announced FDA approval for an expanded label for bortezomib (Velcade). The treatment is now approved for use without dosage adjustments in patients with impaired kidney function, including those requiring dialysis. According to the company, the results of the recent study satisfy a post-approval commitment to the FDA required as part of the drug's 2003 approval. Bortezomib is indicated for the treatment of both multiple myeloma and mantle cell lymphoma in patients who have received at least one prior therapy.