The second-line indication comes with safety labeling recently approved for BCMA-targeted CAR-T competitor Abecma, particularly around increased early mortality and secondary malignancies.

Labeling describes early death imbalance that delayed approval of Bristol Myers Squibb’s CAR-T therapy for more than three months after its user fee goal, but does not add to boxed warning; J&J’s Carvykti is due for imminent US FDA action on its own early-stage myeloma bid.

The US FDA approved Abecma for multiple myeloma after two prior lines of therapy, while the agency was also expected to imminently decide on earlier-line approval for J&J/Legend’s Carvykti.

As drug pricing continues its ascent among hot button issues, the multi-million-dollar price tags for one-and-done advanced therapies, their justification and reimbursement all remain unaligned.