FDA begins safety review of CAR-T therapy after patient deaths


The American regulator has begun a safety review of CAR-T cell therapy anticancer drugs. Hospitalizations and deaths have been reported following their use.

The US Food and Drug Administration (FDA) has initiated a safety review of CAR-T cell therapy anticancer drugs. The American regulator reported this on its official website.

The checks were a consequence of the development of T-cell malignancies in the blood of patients after the use of CAR-T-cell therapy. According to the regulator, hospitalizations and deaths have been reported as a result of taking the drugs. Problems with drug safety were identified by reviewing data on side effects that occurred during clinical trials and after the start of commercial sales. At the same time, the FDA emphasizes that it excludes the revocation of approvals for the use of approved drugs – the benefits still outweigh the risks of taking them.

Since 2017, the FDA has approved six CAR-T cell therapies: Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel) from Bristol-Myers Squibb, Carvykti (ciltacabtagene autoleucel) from Johnson & Johnson, Kymriah (tisagenlecleucel) from Novartis, Tecartus ( brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel) from Gilead Sciences. All drugs have been registered for the treatment of various types of blood cancer.

In Russia, the first gene therapy drug for CAR-T cell therapy in oncology was registered in April 2023. Kymriah (INN tisagenlecleucel 1.2 cell) is indicated for the treatment of acute lymphoblastic leukemia in patients aged three to 25 years, as well as relapsed or refractory diffuse large B-cell lymphoma in adult patients, MB reported.



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