The US Food and Drug Administration (FDA) has approved Johnson and Johnson (J&J) and Legend Biotech’s chimeric antigen receptor (CAR)-T cell therapy, Carvykti (ciltacabtagene autoleucel) as a second-line therapy for patients with multiple myeloma (MM).

There has been increasing scrutiny of CAR-T cell therapies in the last few months. The field has been hit by a few setbacks, including the FDA launching an investigation into the risk of developing secondary cancers, following the administration of CAR-T cell therapies in November 2023.

Despite the concerns, the FDA advisory committee (AdCom) decided that the benefits outweigh the risks for Carvykti as an earlier-line therapy in patients with multiple myeloma.  The FDA approved Carvykti as a fifth-line therapy for relapsed or refractory multiple myeloma in 2022.

The therapy generated $500m in global sales in 2023, as per J&J’s financials. Carvykti sales are expected to grow over the next decade, with the therapy generating approximately $6.8bn in revenue in 2030, as per GlobalData analysis.

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Concurrent with Carvykti’s approval, the US FDA also approved its competitor Bristol Myers Squibb (BMS)’s B-cell maturation antigen (BCMA) directed CAR-T cell therapy, Abecma (idecabtagene vicleucel), as a third-line treatment for multiple myeloma.

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The FDA approval for Carvykti was based on the data from the Phase III CARTITUDE-4 study (NCT04181827). The data from the trial showed that 73% of patients on Carvykti experienced complete remission while the overall response rate (ORR) was 85%. The FDA also added the boxed warning for multiple side effects, including cytokine release syndrome and secondary cancers.

Legend has also applied for a type II variation for the Carvykti label with the European Medicines Agency (EMA). The label variation, if approved, would mean that Carvykti can be used as a second-line treatment for MM.

Earlier this year, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the second-line label expansion. 

Legend has a pipeline of CAR-T cell therapies. In November 2023, the company signed a licensing deal for Delta-like ligand protein 3 (DLL3)-targeting CAR-T cell therapies worth up to $1.01bn with Novartis.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva

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