BRIEF—EMA approves variation for Kite’s CAR-T cell therapies

The European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) from Gilead Sciences’ Kite subsidiary.

The variation includes a reduction in daily hospital safety monitoring for patients following CAR T-cell therapy infusion from ten to seven days, which 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 h   ematological cancers in adults.

“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.