FDA approves J&J and Legend’s Carvykti for second-line multiple myeloma
06 Apr 2024
Drug ApprovalCell TherapyImmunotherapy
The FDA has expanded the label for Johnson & Johnson and Legend Biotech’s multiple myeloma CAR-T therapy to make it a much earlier treatment option for patients, J&J
announced
late Friday night.
The regulator approved Carvykti for multiple myeloma patients who have received at least one prior line of therapy. The cell therapy was first approved in 2022 as a fifth-line option, making it available only to patients who’d already exhausted many of their treatment choices. It generated $500 million in global sales last year, and TD Cowen analysts expect the therapy to bring in $950 million in sales this year following the label expansion.
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