FDA is no longer required to report two common but sometimes serious side effects of a small number of CAR-T treatments in order to "minimize the burden on the health care system". 

Cytokine release syndrome (CRS) and neurotoxicity are two well-known side effects in CAR-T therapy, which belong to immune system overreaction. Last week, regulators removed the requirement for clinicians to report cases of severe side effects as part of their risk assessment and mitigation strategy (REMS) for Gilead's treatment drugs Yescarta and Tecartus. 

In March and April, the agency approved similar updates for Bristol-Myers Squibb's Breyanzi and Bristol-Myers Squibb and 2seventy bio Abecma, respectively.

James Kochenderfer, a senior researcher at the National Cancer Institute, told Endpoints News on Tuesday that it makes sense to reduce reporting requirements because the field has collected large amounts of data from thousands of patients and developed guidelines for the treatment of CRS and neurotoxicity. 

"over the years, we have learned more and more about the treatment of CRS and neurotoxicity," James Kochenderfer said. As a result of early treatment, the toxicity is much less now than in the past. " He has received research grants from Bristol-Myers Squibb and Gilead. 

FDA also removed a number of other requirements for Tecartus and Yescarta REMS, including educational and training materials such as guidelines for adverse reaction management. "as CAR-T cell therapy becomes a more standard treatment, the knowledge, skills and experience needed to provide CAR-T safely and effectively is growing, and oncologists can manage side effects appropriately," a Gilead spokesman said.

A spokesman for Gilead said: "as CAR-T cell therapy has become a more standard treatment and the knowledge, skills and experience needed to provide safe and effective CAR-T has increased over the same period, oncologists can now properly manage side effects." 

The safety of CAR-T has been a concern this year after FDA investigated rare reports of T-cell malignant tumors in CAR-T patients and identified the need for a black box warning in April. 

It is worth mentioning that FDA's decision marks a growing confidence in the safety and effectiveness of CAR-T therapy. This confidence comes not only from the accumulation of clinical data, but also from the progress in understanding the mechanism of CAR-T therapy. Secondly, the relaxation of side effect reporting requirements also reflects FDA's attention to the optimization of health care service system. In the current medical environment, the health care service system is facing tremendous pressure, including shortage of resources, lack of manpower and so on. Relaxing reporting requirements for common side effects will help reduce the burden on medical institutions and enable them to better focus on treating and managing serious or rare adverse reactions that really require attention. Perhaps this is a good signal for the CAR-T cell therapy industry.