Myeloma: FDA Advisers Greenlight Early CAR-T

Receive email when new articles are published onAn advisory panel at the US Food and Drug Administration lent support to bids that allow for earlier use of chimeric antigen receptor therapies in treating, while also calling for clear disclosure to patients of potential risks of these treatments.

Both CAR-T treatments currently are approved for RRMM after 4 or more prior lines of therapy, including an IMiD, PI and an anti-CD38 monoclonal antibody. Last year BMS and Janssen filed their separate applications, both seeking to have their drugs used earlier in the course of RRMM. In its review of the ide-cel application, the FDA staff said the median PFS was 13.3 months in the ide-cel arm , and 4.4 months in the standard of care arm.

In response, Robert Sokolic, MD, the branch chief for malignant hematology at FDA, replied that the data raised concerns that did in fact remind him of these procedures. In contrast, the primary endpoint in the key studies for expansion of CAR-T drugs was progression-free survival , with overall survival as a second endpoint. The FDA staff in briefing documents noted how overall survival, the gold standard in research, delivers far more reliable answers for patients and doctors in assessing treatments.

In its briefing document for the meeting, BMS emphasized that most of the patients in the ide-cel arm who died in the first 6 months of its trial did not get the study drug. There were 9 deaths in the standard-regimen arm, or 6.8% of the group, compared with 30, or 11.8% in the ide-cel group.

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