The Oncologic Drugs Advisory Committee (ODAC) voted 10-0 in favor of approval after hearing reports from FDA staff and Novartis regarding the development, manufacturing, efficacy, and safety of CTL019, the first-ever auto T-cell therapy submitted for FDA approval.
A novel cell treatment that saved the life of 9-year-old Austin Schuetz was given the green light by U.S. regulatory advisers on Wednesday and doctors hope it can save the lives of more children with the most common type of childhood cancer.
In 2012, Novartis and Penn signed a collaboration to further research, develop and commercialize CAR-T cell therapies, including CTL019, for the investigational treatment of cancers.
Short for chimeric antigen receptor T-cell therapy, CAR-T treatment takes a person's own cells, removes them from the body, re-engineers them, and then puts the cells back in the body where they can attack cancer cells. The agency doesn't have to follow the committee's recommendation but usually does.
If cleared by the FDA, it would be the first gene therapy approved in the United States.
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During the committee meeting, hundreds of people packed the hearing room at FDA headquarters in Silver Spring, Md., including prominent scientists, such as Carl June of the University of Pennsylvania, who developed the treatment.
Novartis applied for the approval for its drug, tisagenlecleucel, to treat acute lymphblastic leukemia in children who have exhausted all the existing treatments for the disease. In a clinical trial, the treatment left 83 percent of participants cancer-free after three months, results the independent experts hailed as a major advance for patients with few other options.
In order to make use of the "living drug", a small sample of the patient's T-cells - white blood cells which are involved in fighting infection - is removed from their blood and sent to the laboratory for testing.
In the main study that the company submitted as evidence in seeking FDA approval, doctors at 25 sites in 11 countries administered the treatment to 88 patients.
The complication doesn't apply universally across all CAR-T products, and newer generations now in development appear able to avoid the permanent destruction of B cells.
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The treatment does carry several short-term side effects, which include fever and hallucinations. Cancer cells arise from normal cells, so the immune system doesn't always recognize that anything is wrong. This is also why companies like GE Healthcare are jumping into cell therapy manufacturing to offer companies like Novartis, Kite, and Juno large-scale production services. These are then injected back into the patient.
The FDA's Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel) for the treatment of relapsed or refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL).
There are still plenty of challenges ahead for Novartis and other companies in the CAR-T space.
The first ever approval of a new kind of cancer immunotherapy called CAR-T is one step closer. The drug would only be used, however, if the disease failed to respond to standard treatment.
While the permanence of the manipulated cancer killers is good for eliminating the blood malignancy, it's bad for the immune system.
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When approved, the treatment will initially be available at 30 or 35 dedicated centres in the US. The trial found that of the 51 patients with DLBCL, 23 had either a complete response (meaning cancer had disappeared completely) or a partial response (meaning their tumor displayed signs that it was shrinking). She also noted that once the therapy is marketed, patients will be lost to the follow-up that's needed to determine long-term effects. "As an investor I've never seen anything like it".
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