EU clears J&J's myeloma cell therapy Carvykti for second-line use
22 Apr 2024
Drug ApprovalPhase 3Cell TherapyClinical ResultImmunotherapy
Regulators in the EU have approved Johnson & Johnson and Legend Biotech's Carvykti (ciltacabtagene autoleucel) for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy.
The decision comes shortly after US regulators expanded the BCMA-directed CAR-T drug's label for the same indication.
Carvykti was first granted a conditional marketing authorisation in Europe in 2022 in the fourth-line setting, backed by the Phase Ib/II CARTITUDE-1 study.
The latest approval was based on the Phase III CARTITUDE-4 trial, which evaluated Carvykti versus standard regimens in adults with relapsed and lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy. A single infusion of Carvykti reduced the risk of disease progression or death by 59% compared to standard regimens, meeting the primary endpoint.
Jordan Schecter, disease area leader for multiple myeloma at Johnson & Johnson, said the drug "is an important part of how we are working to redefine multiple myeloma and ultimately achieve sustained remissions for patients."
Bristol Myers Squibb's competing CAR-T Abecma (idecabtagene vicleucel) beat Carvykti to a broader EU label by about a month, although it was cleared for use in the third-line setting. Concerns about early deaths have been flagged for both treatments.
Meanwhile, Johnson & Johnson touted Carvykti as one of its stronger oncology performers so far this year, generating $157 million in sales during the first quarter, more than double the corresponding year-ago period. However, that still missed consensus of $200 million for the product. For more, see Vital Signs: Bispecifics challenge CAR-T in the BCMA revenue race.
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