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Johnson & Johnson (NYSE:JNJ) announced Tuesday that its FDA-approved cell therapy Carvykti, developed with Legend Biotech (LEGN), outperformed standard of care in a Phase 3 trial for patients with a type of blood cancer called multiple myeloma.
Citing interim data from its CARTITUDE-4 trial, the pharma giant said patients who received Carvykti after one prior line of therapy survived longer (overall survival) than those on standard therapies, namely PVd and DPd.
The company noted that the results were statistically significant and clinically meaningful, and added that they were consistent with the drug’s approved label.
“CARVYKTI, a one-time infusion, is now the first cell therapy to significantly improve overall survival versus standard of care for patients with myeloma as early as second line,” said Jordan Schecter, who heads J&J’s multiple myeloma programs.
In April, the FDA expanded the label of Carvykti, a BCMA-targeting CAR-T cell therapy for adults with multiple myeloma who have received at least one prior line of therapy.
Approval came a day after the agency cleared a label expansion for another cell therapy Abecma, developed by Bristol Myers Squibb (BMY) and 2seventy bio (TSVT) for adults with multiple myeloma who have undergone at least two prior lines of therapy.