The approval expands the chimeric antigen receptor (CAR) T-cell therapy’s indications to earlier lines of treatment after exposure to these other main therapy classes, Bristol Myers Squibb said in a press release.
Approval was based on the KarMMa-3 trial, in which 254 patients were randomly assigned to ide-cel and 132 to investigators’ choice of standard regimens, consisting of combinations of daratumumab, dexamethasone, and other agents.
After a median follow-up of 15.9 months, median progression-free survival was three times higher in the ide-cel arm: 13.3 months with the CAR T-cell therapy vs 4.4 months with standard treatment. Overall, 39% of patients on ide-cel had a complete response vs 5% on standard regimens.
The approval includes a new recommended dose range of 300-510 x 106 CAR-positive T cells.
Ide-cel carries a boxed warning for cytokine release syndrome, neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, prolonged cytopenia, and secondary hematologic cancers.
In trials, cytokine release syndrome occurred in 89% (310 of 349) of patients in the KarMMa-3 and KarMMa studies, which included grade 3 syndrome in 7% (23 of 349) and fatal cases in 0.9% (3 of 349) of patients.
A one-time treatment is over $500,000, according to drugs.com.
A version of this article appeared on Medscape.com.