Apr 3, 2022
Johnson & Johnson (NYSE:JNJ) has received FDA approval to expand the current labeling for its CAR-T cell therapy, Carvykti, developed in partnership with Legend Biotech (NASDAQ:LEGN), to include adults with the blood cancer multiple myeloma in an earlier-line setting.
Accordingly, the treatment-targeting B-cell maturation antigen (BCMA) will be indicated in the U.S. for adults with relapsed or refractory multiple myeloma who have previously received at least one prior line of cancer therapy.
Multiple myeloma, a type of blood cancer that impacts white blood cells called plasma cells, is expected to affect over 35,000 people, leading to more than 12,000 deaths in the U.S.
It has previously been approved for multiple myeloma patients who have received at least four prior lines of therapy. In March, an FDA expert panel unanimously endorsed its label expansion.
On Friday, Bristol Myers Squibb (BMY) announced that the FDA expanded the labeling for its BCMA-targeting CAR-T cell therapy Abecma developed with 2seventy bio (TSVT) to include adults with multiple myeloma who have received two or more prior lines of therapy.
Both treatments come with a boxed warning for adverse events such as cytokine release syndrome.