May 15, 2003
FDA approves Velcade for treatment for relapsed and refractive multiple myeloma
K. Anderson, MD
The U.S. Food and Drug Administration (FDA) today authorized the use of Velcade (TM) (bortezomib) for Injection for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Velcade is a first of a class of substances known as proteasome inhibitors to receive FDA approval for the treatment of cancer, and is the first treatment in more than a decade to be approved for patients with multiple myeloma.
"The FDA approval of Velcade represents a major advance in our fight against multiple myeloma," said Ken Anderson, MD, director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber and the lead investigator in the preclinical development and clinical trials of Velcade. "With its new and unique mechanism of action of inhibiting the proteasome, Velcade is different from traditional chemotherapies and represents a new treatment option for patients."
Approximately 14,600 new cases of multiple myeloma will be diagnosed in the United States in 2003 and 10,800 people likely will die from the disease.
P. Richardson, MD
Anderson, along with his Dana-Farber colleagues Paul Richardson, MD, and Teru Hideshima, MD, contributed to the development of Velcade and then directed the clinical trials. The FDA based its approval, in part, on data from these trials.
Velcade acts on tiny cell chambers called proteasomes, preventing multiple myeloma cells from proliferating, even those that were resistant to all known therapies. Laboratory studies have shown that the drug killed myeloma cells without seeming to harm normal tissue.
"Velcade represents a new treatment paradigm that targets the tumor cells and the bone marrow microenvironment to overcome drug resistance," said Anderson. "This offers clinicians a greater potential to improve patient outcome."
The FDA's approval of Velcade comes four and a half years after the start of the first trial in humans, an indication of the importance of the drug and proteasome inhibition. The development and approval of Velcade is among the most rapid for a cancer treatment. As part of this accelerated approval, Millennium will be completing preclinical and phase IV clinical studies, including a study of previously untreated multiple myeloma patients.
Millennium Pharmaceuticals of Cambridge, Mass., is the manufacturer of the drug, formerly known as PS341. In addition to their work on the pre-clinical and clinical development of Velcade, Dana-Farber researchers will continue to work closely with Millennium and investigators from other clinical and academic institutions to study Velcade.
Dana-Farber Cancer Institute is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.
