US Food and Drug Administration fast-tracks novel leukemia therapy

the ONA take:

An experimental immunotherapy agent was placed on the US Food and Drug Administration’s fast track to market approval after overwhelmingly positive results were seen in patients with leukemia. In early trials, 89% of patients who received the personalized immunotherapy known as CTL019 saw their cancers disappear. The approach works by extracting a patient’s T-cells and genetically programming them to target cancer cells that produce the protein CD19. The altered T-cells are then re-injected into the patient, where they multiply and attack the cancer. Of the 27 study participants (22 children and five adults), 89% had a complete response. The first child to receive the treatment is 2 years in remission, and the first adult patient has been in remission for 1 year. In addition to acute lymphoblastic leukemia, trials using CTL019 are underway in patients with relapsed and refractory chronic lymphocytic leukemia, non-Hodgkin lymphoma, and myeloma.

US Food and Drug Administration fast-tracks novel leukemia therapy
US Food and Drug Administration fast-tracks novel leukemia therapy
US regulators on Monday put an experimental immunotherapy agent on the fast track to market approval, after 89 percent of leukemia patients in early trials saw their cancers disappear. The personalized immunotherapy known as CTL019 was developed by the University of Pennsylvania and was designated a "breakthrough therapy" by the US Food and Drug Administration.
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