Johnson & Johnson (J&J) is gearing up for a significant challenge to its burgeoning BCMA CAR T cell therapy, Carvykti, as Gilead Sciences prepares to launch anitocabtagene autoleucel (anito-cel) in 2026. Currently, J&J’s Carvykti is a leading therapy for multiple myeloma, with sales rapidly approaching blockbuster status and projections indicating peak sales around $7 billion by 2030. However, Gilead’s CAR-T unit, Kite, has an even more ambitious outlook, forecasting the overall multiple myeloma CAR-T market could reach $15 billion to $20 billion by 2034, significantly larger than Gilead’s current lymphoma CAR-T stronghold.
Gilead’s strategy to capture market share, despite J&J’s multi-year head start, hinges on positioning anito-cel with better safety and at least comparable efficacy. Manufacturing capabilities are also a key differentiator, with Gilead leveraging its established infrastructure for other CAR-T therapies. Recent Phase II data for anito-cel in relapsed or refractory multiple myeloma, shared by Gilead’s partner Arcellx, demonstrated impressive results, including a 97% overall response rate and nearly 70% complete response rate. Analysts have noted anito-cel’s efficacy is comparable to Carvykti’s, with a potentially superior 12-month overall survival rate (95% vs. Carvykti’s 89%).
A critical competitive advantage for anito-cel lies in its safety profile, particularly the notably low rates of neurotoxicity. Unlike Carvykti, which carries a boxed warning for serious adverse events including Parkinsonism and Guillain-Barré syndrome, the anito-cel trial has reported no such severe neurotoxicities. Furthermore, anito-cel showed a very low 1% rate of Grade 3 or above cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS), both of which are major concerns with CAR-T therapies.
Gilead aims to significantly expand the CAR-T multiple myeloma market by enabling outpatient administration of anito-cel. The company highlights that only about 10% of eligible multiple myeloma patients currently receive CAR-T, partly due to the required hospital stays. By allowing treatment in community settings, where most myeloma patients receive care, Gilead believes it can dramatically increase patient access and uptake. Gilead has already initiated outpatient treatment in its trials and plans to use its extensive global network of over 550 authorized treatment centers to support this model.
However, J&J is not conceding its lead without a fight. Some analysts caution against direct cross-trial comparisons between anito-cel and Carvykti due to differences in study populations and management protocols. J&J remains confident in Carvykti, citing its demonstrated statistically significant improvements in overall survival and its FDA approval for second-line use, giving it a head start in earlier treatment lines. J&J is also actively exploring outpatient dosing for Carvykti through ongoing trials, aiming to match Gilead’s flexibility. The coming years will see an intense battle for market share as both companies vie to expand their reach in the lucrative multiple myeloma CAR-T therapy landscape.
