EU relaxes safety monitoring of CAR-T therapies

The European Medicines Agency has approved a Type II variation to the Summary of Product Characteristics (SmPC) for Kite’s chimeric antigen receptor (CAR)-T cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). The variation includes a reduction in daily hospital safety monitoring for patients following CAR-T cell therapy infusion from 10 to seven days. The decision to reduce this was supported by further data from clinical trials, post-marketing studies, and updated peer-reviewed publications. The updated safety monitoring timelines apply across all approved indications for axicabtagene ciloleucel and brexucabtagene autoleucel in difficult-to-treat haematological cancers in adults. Axicabtagene ciloleucel is approved by the European Commission (EC) to treat adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL). Brexucabtagene autoleucel is approved for patients with mantle cell lymphoma and B-cell precursor acute lymphoblastic leukaemia. “This approval is good news for patients, caregivers and physicians, and support capacity in healthcare systems for eligible patients,” said Dominique Tonelli, Executive Director, Head of Medical Affairs, ACE, Kite. “It reinforces the wealth of clinical and real-world evidence available for axicabtagene ciloleucel and brexucabtagene autoleucel, that supported this reduction in monitoring timelines, and enabling physician discretion in the subsequent management of their patients.” In November 2023, the US Food and Drug Administration launched an investigation into the safety of BCMA- or CD19-directed autologous CAR-T cell immunotherapies, following reports of T cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in these patients. In response, the International Society for Cell & Gene Therapy (ISCT) published an expert consortium commentary stating that the benefits of CAR-T therapies continue to outweigh potential risks in the vast majority of cases. Real-world evidence from the French DESCAR-T registry has also supported the use of axicabtagene ciloleucel in large B-cell lymphoma (LBCL) patients. Diana Spencer, Senior Digital Content Editor, DDW