Velcade® Approved as Second-Line Therapy for Recurrent Multiple Myeloma

Velcade® Approved as Second-Line Therapy for Recurrent Multiple Myeloma.

The U.S. Food and Drug Administration recently approved Velcade® (bortezomib) for the treatment of recurrent multiple myeloma in patients who have received at least one prior therapeutic regimen. The previous indication included Velcade® for the treatment of patients with multiple myeloma who had received at least 2 prior treatment regimens, and had demonstrated cancer progression during their last therapy.

Multiple myeloma is a cancer involving important immune (infection-fighting) cells called plasma cells. Plasma cells aid the body in fighting infection by producing specialized proteins called antibodies that have the ability to target and/or kill foreign cells. In multiple myeloma, cancerous plasma cells produce abnormal and excessive antibodies that do not have the ability to properly fight infection. In addition, the cancerous plasma cells accumulate in the bone marrow, suppressing the normal formation and function of other cells that are necessary for normal production of blood cells and immune functions. The excessive accumulation of cancer cells in the bone marrow ultimately leads to the formation of tumors in the bone and to the breakdown of bone. Furthermore, the cancerous plasma cells secrete dysfunctional antibodies, referred to as M proteins, which can be measured in the blood. Once multiple myeloma returns following prior therapy, it is referred to as recurrent. Patients with recurrent multiple myeloma have limited effective treatment options that are easily tolerated.

Proteosomes are proteins existent in virtually every cell that are responsible for the breakdown and re-use of other proteins in a cell. Through regulating several aspects of cellular activity, proteosomes are greatly responsible for activation of survival pathways of a cell. Velcade®, a proteosome inhibitor, has demonstrated an inhibitory effect on cellular survival through its activity on proteosomes. In addition, Velcade® has demonstrated the ability to re-sensitize cancer cells to the killing effects of chemotherapy in refractory myeloma cells. Evaluation of Velcade® continues in the treatment of different stages of multiple myeloma, as well as in the treatment of other types of cancers.

The trial that prompted the additional approval of Velcade® included 669 patients with multiple myeloma who had received at least one prior therapy. Patients were treated with either Velcade®, or dexamethasone (a steroid that is often used to treatment multiple myeloma). Overall anti-cancer response rates were 38% for patients treated with Velcade®, compared to only 18% for those treated with dexamethasone. The overall duration of survival was also significantly improved in the group of patients treated with Velcade® compared to the group treated with dexamethasone. The most common side effects of Velcade® were weakness, diarrhea, nausea, fatigue, constipation, and tingling or burning of the hands or feet.

Patients with recurrently multiple myeloma may wish to speak with their physician about their individual risks and benefits of treatment with Velcade®.

Reference: Millennium Pharmaceuticals. Bortezomib prescribing information. Available at: . Accessed March 2005.

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