Ciltacabtagene Autoleucel

A new retrospective analysis has added to building evidence that suggests chimeric antigen receptor T-cell therapy does not directly cause secondary malignancies.

Patients who received chimeric antigen receptor T-cell therapy did not exhibit increased risk for second primary malignancies compared with those who received other standard treatments, according to a systematic review and meta-analysis.

The FDA approved ciltacabtagene autoleucel for earlier use in certain adults with relapsed or refractory multiple myeloma.

The FDA has requested manufacturers of commercially available chimeric antigen receptor T-cell therapies now include a boxed safety warning regarding the risk for secondary T-cell malignancies on prescribing labels.

Benefits of chimeric antigen receptor T-cell therapy far outweigh the risks involved, including secondary T-cell malignancies, according to Peter Marks, MD, PhD, director of the FDA’s Center for Biologic Evaluation and Research.

The FDA published a safety advisory on the risk of T-cell malignancies among individuals receiving autologous chimeric antigen receptor T-cell therapy for the treatment of certain blood cancers.

Patients with multiple myeloma who exhibited sustained minimal residual disease negativity after treatment with ciltacabtagene autoleucel achieved longer PFS and duration of response, according to study results.

Now that chimeric antigen receptor T-cell therapy has become part of the treatment landscape in hematologic malignancies, researchers are focused on developing more potent, less toxic agents that can be used in earlier treatment settings.

Nearly 7,000 abstracts had been submitted for presentation at this year’s ASCO Annual Meeting.

The FDA announced several regulatory actions the past few weeks.