Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti.Two days after presenting remarkable data from a phase 3 trial in multiple myeloma at the American Society of Clinical Oncology annual meeting, the companies have filed with the FDA for expanded use of the cell therapy.
After gaining approval 16 months ago for Carvykti to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment.
Specifically, Legend and J&J submitted an application seeking an approval to treat patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a protease inhibitor, such as Takeda’s Velclade, and an immunomodulatory agent, such as Bristol Myers Squibb’s Revlimid.
With such an approval, Carvytki could leapfrog BMS’ multiple myeloma CAR-T Abecma, which was approved for fourth-line use in 2021.
Legend and J&J are basing their submission on data from the CARTITUDE-4 study, which showed that Carvykti—in patents who had undergone one to three prior lines of treatment—cut the risk of disease progression or death over the standard of care by 74%.
More impressively, those in the study who had received two to three prior lines of therapy saw a 76% reduction in disease progression or death, versus 65% in those who had undergone one prior line.
“This submission brings us one step closer to potentially helping more patients facing relapsed and refractory multiple myeloma, as we continue to explore the potential of Carvykti,” Ying Huang, Ph.D., Legend’s CEO, said in a release.
The companies have high hopes for the drug, pinning its peak sales at $5 billion. Getting there will likely require the treatment to score approval for first-line use.
J&J and Legend have already launched their front-line bid, with the phase 3 CARTITUDE-5 trial testing Carvykti’s use following a combination of Velcade, Revlimid and dexamethasone (VRd) in newly diagnosed multiple myeloma patients not intended for transplant.

Reference: https://www.fiercepharma.com/pharma/jj-legend-file-expanded-use-carvykti-multiple-myeloma