Elotuzumab Earns U.S. Food and Drug Administration Breakthrough Therapy Designation for Multiple Myeloma

Posted on May 26th, 2014 by

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the drug elotuzumab for use in previously treated, or relapsed, multiple myeloma. This announcement was recently made in a press release from drug-maker Bristol-Myers Squibb.[1]

Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.

Elotuzumab is an investigational drug, a humanized monoclonal antibody, which binds to a protein (the CS1 glycoprotein) commonly found on myeloma cells and rarely found on normal cells. This treatment allows the immune system to selectively kill myeloma cells.

The Breakthrough Therapy Designation is for elotuzumab to be used in combination with Revlimid® (lenalidomide) and low-dose dexamethasone in multiple myeloma that has progressed after previous treatment. The FDA grants Breakthrough Therapy Designation to accelerate the development and review of drugs for serious or life-threatening conditions. To qualify, a drug must show in early research that it can improve outcome more effectively than available therapy.

Elotuzumab, in combination with lenalidomide and low-dose dexamethasone, was proven active against relapsed multiple myeloma in a 2011 Phase II clinical trial. Overall, 82% of patients in the trial responded to treatment.[2]

According to Bristol-Myers Squibb, the Breakthrough Therapy Designation for elotuzumab marks important progress in the treatment of relapsed multiple myeloma. “Despite recent advances in the treatment of relapsed or refractory multiple myeloma, it remains an area of unmet need,” said a representative for the drug-maker.

References:


[1] Bristol-Myers Squibb and AbbVie Receive U.S. FDA Breakthrough Therapy Designation for Elotuzumab, an Investigational Humanized Monoclonal Antibody for Multiple Myeloma [press release]. Bristol-Myers Squibb. Available at: http://news.bms.com/press-release/rd-news/bristol-myers-squibb-and-abbvie-receive-us-fda-breakthrough-therapy-designatio

[2] Richardson PGG, Moreau P, Jakubowiak AJ et al. Elotuzumab with lenalidomide and low-dose dexamethasone in patients with relapsed multiple myeloma: a randomized phase II study. Paper presented at: 2011 Annual  Meeting of the American Society of Clinical Oncology; June 3-7, 2011; Chicago, IL. Abstract 8014. Meeting of the American Society of Clinical Oncology; June 3-7, 2011; Chicago, IL. Abstract 8014.

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Tags: Multiple Myeloma, News, Recurrent Multiple Myeloma

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