FDA Expands VELCADE(R) (Bortezomib) for Injection Label for Patients with Multiple Myeloma
Monday October 15, 9:00 am ET
- Underscores Benefit for Patients with Kidney Impairments -
- Highlights Leading Role of VELCADE in Broad Range of Patients -
CAMBRIDGE, Mass., Oct. 15 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced that the U.S. Food and Drug Administration (FDA) granted approval for VELCADE use, without dose adjustments, in patients with impaired kidney function, including those requiring dialysis. Impaired kidney function is a common complication related to multiple myeloma (MM), affecting approximately 30 percent of patients at diagnosis and a much larger percentage throughout the course of the disease.
"The ability to use VELCADE without dose adjustments in patients with renal dysfunction differentiates it from other multiple myeloma therapies," said Paul Richardson, M.D., Clinical Director, Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute Boston 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."
"This expansion of the VELCADE label confirms that patients with impaired kidney function can receive the full benefit of VELCADE," said Sundar Jagannath, M.D., St. Vincent's Comprehensive Cancer Center, New York. "Since renal impairment is not an uncommon complication of the disease, VELCADE 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 impairments. The results of this study satisfy a post-approval commitment, which was required by the FDA when VELCADE was approved in 2003.
"This label expansion underscores the role of VELCADE as the market- leading therapy in relapsed multiple myeloma, and we believe it will be important as we seek 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, M.D., Executive Vice President, Commercial, Millennium. |
