J&J and Legend Biotech’s Carvykti is a B-cell maturation antigen (BCMA) directed CAR-T cell therapy. Image Credit: Corona Borealis Studio / Shutterstock.

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.

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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. 

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.