The FDA has approved Bristol Myers Squibb and 2seventy Bio’s CAR-T therapy, Abecma, for earlier use in treating multiple myeloma, a type of blood cancer. This approval permits the use of Abecma in adults who have already received at least two prior treatments for relapsed or refractory forms of the disease.
The FDA’s decision, which came three weeks after a panel of FDA advisers endorsed earlier treatment, follows concerns raised by agency reviewers regarding an increased risk of death among participants in the companies’ main trial during the first year. Despite these concerns, trial results indicated that Abecma reduced the risk of disease progression or death by approximately 50% compared to standard regimens.
Bristol Myers and 2seventy had initially anticipated an expanded approval for Abecma by mid-December, but the FDA postponed its decision to seek guidance from its advisory panel. The expert committee go together in mid-March and discussed the benefits of both Abecma and a rival CAR-T therapy, Carvykti, from Johnson & Johnson and Legend Biotech. Ultimately, they voted in favor of both therapies, emphasizing the significant treatment benefits despite the associated risks.
Abecma targets a protein called BCMA, found on malignant B cells in multiple myeloma patients. Its earlier approval for later-line treatment provided an additional option for patients, as the disease often requires switching treatments due to relapse or resistance.
Now stepping in after just two treatments, Abecma’s expanded reach promises to shake up the treatment landscape for multiple myeloma.
CAR-T therapies, personalized treatments manufactured from the immune cells of individual patients, pose complex manufacturing challenges. Nonetheless, Bristol Myers boasts a manufacturing success rate of 94% for the therapy in the commercial setting.
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