pharmaphorum November 28, 2023
The FDA has announced it will start an investigation into the safety of CAR-T therapies, after becoming concerned that they may be linked to the development of T-cell cancers.
The probe is directed at all CAR-Ts currently on the US market, including those that target CD19 as well as BCMA, which are used to treat a range of haematological malignancies including various forms of non-Hodgkin’s lymphoma, acute lymphoblastic leukaemia (ALL) and multiple myeloma.
In a statement, the FDA said it had received reports of T-cell malignancies – including chimeric antigen receptor (CAR) positive lymphoma – in patients who had received both types of CAR-T therapy.
The regulator highlighted the products by name, including Bristol-Myers Squibb’s Breyanzi (lisocabtagene maraleucel) and 2seventy...
Today's Sponsors
Today's Sponsor