Novartis has to include new risks for anti-cancer wonderdrug Kymriah
The American regulator now requires the Swiss pharma giant to include new risks for its immunotherapy for acute lymphoblastic leukaemia.
The US Food and Drug Administration (FDA) is forcing producers of immunotherapies based on genetically modified autologous T lymphocytes (CAR-T), including Novartis, which pioneered the field with its Kymriah (tisagenlecleucel), to include new risks in the package leaflets accompanying these treatments.
In a publication published on Monday evening, the FDA points out that it has identified new risks of T-cell cancer since the approval of Kymriah at the end of August 2017, which could require hospitalisation or even lead to the death of treated patients. The authority stresses that this is “new safety information” and considers that it applies to all CAR-Ts targeting the BCMA- and CD19 proteins.
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At the end of last year, the regulator announced that it was conducting an investigation into this type of treatment, produced by Novartis as well as Gilead Sciences, Johnson and Johnson and Kite Pharma, among others.
Novartis caused a sensation on August 30, 2017 when it obtained the green light in the US to market a first-ever cellular immunotherapy for acute lymphoblastic leukaemia (ALL). At the time, the price of the treatment was set at $475,000.
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