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Penn's immunotherapy for leukemia receives FDA's Breakthrough Therapy designation
Date:7/7/2014

PHILADELPHIA A University of Pennsylvania-developed personalized immunotherapy has been awarded the U.S. Food and Drug Administration's Breakthrough Therapy designation for the treatment of relapsed and refractory adult and pediatric acute lymphoblastic leukemia (ALL). The investigational therapy, known as CTL019, is the first personalized cellular therapy for the treatment of cancer to receive this important classification.

In early-stage clinical trials at the Hospital of the University of Pennsylvania and the Children's Hospital of Philadelphia, 89 percent of ALL patients who were not responding to conventional therapies went into complete remission after receiving CTL019.

"Our early findings reveal tremendous promise for a desperate group of patients, many of whom have been able to return to their normal lives at school and work after receiving this new, personalized immunotherapy," said the Penn research team's leader, Carl June, MD, the Richard W. Vague Professor in Immunotherapy in the department of Pathology and Laboratory Medicine in the Perelman School of Medicine and director of Translational Research in the Abramson Cancer Center of the University of Pennsylvania. "Receiving the FDA's Breakthrough Designation is an essential step in our work with Novartis to expand this therapy to patients across the world who desperately need new options to help them fight this disease."

The FDA's Breakthrough Therapy designation, created in 2012, is intended to expedite the development and review of new medicines both drugs and biologic agents that treat serious or life-threatening conditions, if the therapy has demonstrated substantial improvement over available therapies. The FDA has previously granted Breakthrough Therapy to only four other biologic agent
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Contact: Steve Graff
stephen.graff@uphs.upenn.edu
215-349-5653
University of Pennsylvania School of Medicine
Source:Eurekalert

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