FDA Just Made Some Key Regulatory Changes to Make Cancer Cell Therapies More Accessible

USFDA lifts Risk Evaluation and Mitigation Strategies for CAR T cell therapies

The U.S. Food and Drug Administration (USFDA) has announced that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous...

FDA Just Made Some Key Regulatory Changes to Make Cancer Cell Therapies More Accessible

The FDA has eliminated a safety monitoring requirement and eased certain restrictions that had been in place since CAR T-therapies first reached the market in 2017. The agency and financial analysts say the changes should improve patient access to these personalized cancer treatments.

US FDA Eliminates Risk Evaluation, Mitigation Strategies for CAR-T Cancer Therapies

FDA Relaxes REMS, Monitoring Rules for Liso-Cel and Ide-Cel

The FDA removed REMS and reduced certain monitoring needs for liso-cel and ide-cel in B-cell malignancies.

Treatment Approaches in Multiple Myeloma

Panelists discuss how advancements in treatment options, including chimeric antigen receptor (CAR) T-cell therapy, bispecific antibodies, and antibody-drug conjugates, are shaping the current multiple myeloma landscape.

FDA loosens safety requirements for CAR-Ts in move to boost access

The FDA is eliminating a safety monitoring program for all CAR-T therapies, saying the cell therapies can be used safely and effectively without it. The agency said Thursday it determined the ...