FDA oks Velcade for patients with renal dysfunction

ROCKVILLE, Maryland—FDA has granted approval for use of Millennium Pharmaceuticals' Velcade (bortezomib) in myeloma patients with impaired kidney function without dose adjustments. The expanded label approval includes patients requiring dialysis.

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, Millennium said in a news release.

"The ability to use Velcade without dose adjustments in patients with renal dysfunction differentiates it from other multiple myeloma therapies," said Paul Richardson, MD, clinical director, Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, and associate professor of Medicine, Harvard Medical School. "Physicians treating multiple myeloma patients want the confidence that therapies are not only efficacious but also can be used consistently and predictably."

Sundar Jagannath, MD, of St. Vincent's Comprehensive Cancer Center, New York, said that since renal impairment is not an uncommon complication of the disease, "Velcade now has the potential to benefit the entire population of multiple myeloma patients."

The label expansion is based on data from a prospective phase I pharmacokinetic trial in patients with varying degrees of kidney impairment. The results satisfy a postapproval commitment required by the FDA when Velcade was approved in 2003. "We are seeking to further broaden the Velcade label, using the data from our phase III VISTA trial, to include patients with newly diagnosed multiple myeloma," said Christophe Bianchi, MD, executive vice president, commercial, at Millennium. [See ONI, October 2007, page 40, for interim VISTA trial results.]