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FDA Approval: LLS Applauds New Advance for Acute Lymphoblastic Leukemia

RYE BROOK, N.Y. (August 17, 2017) – The Leukemia & Lymphoma Society (LLS) applauds today’s approval by the U.S. Food and Drug Administration (FDA) of inotuzumab ozogamicin (Besponsa®) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

This year alone, it is estimated that almost 6,000 people in the United States will be diagnosed with ALL. This approval is a significant step forward because it provides a new option for adult patients with ALL who have not responded to treatment, or whose cancer has come back after treatment.

The targeted therapy is an antibody-drug conjugate (ADC), which works by first binding an antibody to the surface of B-cell ALL cancer cells that express the CD22 antigen. When the antibody binds to the cell, it releases a highly potent toxin inside the cell. The toxin, known as calicheamicin, binds to the DNA and then blocks tumor cell growth.

“It has been an incredible journey for calicheamicin, which was discovered in the 1980s, and ultimately conjugated to an antibody,” said Dr. Lee Greenberger, Chief Scientific Officer, LLS. “Although LLS did not have a role in advancing this therapy, we are hopeful about the promise of targeted therapy approaches like this one for cancer patients, who deserve new and more effective treatments.”

This is the fourth antibody drug conjugate approved for the treatment of cancer. The first one, gentuzumab ozogamycin (Mylotarg®), was approved for the treatment of acute myeloid leukemia (AML) in 2000, but later removed from the market in 2010. Mylotarg® is currently being reconsidered by the FDA to return to the market. Other antibody drug conjugates are approved for the treatment of breast cancer and Hodgkin lymphoma.

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.

Founded in 1949 and headquartered in Rye Brook, NY, LLS has chapters throughout the United States and Canada. To learn more, visit Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET. For additional information visit Follow us on FacebookTwitter, and Instagram.