The approval is based on data from a prospective Phase I pharmacokinetic trial in patients with varying degrees of kidney impairments. The results of the study satisfy a post-approval commitment, which was required by the FDA when Velcade was approved in 2003.
Impaired kidney function is a common complication related to multiple myeloma, affecting approximately 30% of patients at diagnosis and a much larger percentage throughout the course of the disease.
Paul Richardson, clinical director of Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute Boston, said: “The ability to use Velcade without dose adjustments in patients with renal dysfunction differentiates it from other multiple myeloma therapies. Physicians treating multiple myeloma patients want the confidence that therapies are not only efficacious, but also can be used consistently and predictably.”