Pediatric Dream Team Secures FDA Breakthrough Therapy Designation for New Immunotherapy to Treat Pediatric Blood Cancer - Stand Up To Cancer

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Posted October 7, 2019

Pediatric Dream Team Secures FDA Breakthrough Therapy Designation for New Immunotherapy to Treat Pediatric Blood Cancer

In August, the FDA granted “breakthrough therapy designation” for a new immunotherapy CAR T-cell treatment for B-cell acute lymphoblastic leukemia (ALL). The breakthrough therapy designation is designed to expedite development and FDA review of the treatment. Development of new immunotherapies for blood cancer have focused on targeting the treatment to specific proteins found in the cancer. Members of the SU2C-St. Baldrick’s Pediatric Cancer Dream Team working in Co-Leader Crystal Mackall’s lab contributed to early clinical evidence that this treatment targeting the “CD22” protein would be a substantial improvement over available therapy for children whose leukemia comes back or doesn’t respond to standard therapy. Prior work of this dream team contributed to the development of the T-cell therapy which targeted a different protein, “CD19,” to treat B-cell leukemia. The CD19 therapy was approved by the FDA in March 2018. Approximately half of children treated with CD19 targeted therapies relapse driving the need for this new treatment. Read more.

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