Shambavi Richard, MD, of the Icahn School of Medicine at Mount Sinai, discusses the implications of the mandate by the US Food and Drug Administration (FDA) to update prescription labelling of the six chimeric antigen receptor (CAR) T-cell therapies indicated to treat blood cancers.
In November 2023, the FDA started an investigation into the secondary T-cell malignancies that were associated with BCMA- or CD19-targeted CAR-T therapies based on cases from clinical trials and postmarketing surveillance, she explained.
“The FDA has now concluded the investigation and mandated label updates for six commercially approved CAR-T therapies,” Dr. Richard said, adding the agency is also “mandating boxed warnings, which is the highest safety-related warning for these medications.”
She noted the mandate could affect moving CAR-T therapies into earlier lines of the treatment paradigm for multiple myeloma.
“As of now, they are approved for advanced myeloma at four or more lines of therapy, and so that does have some major implications,” Dr. Richard said.