Despite the rise of Tecvayli—a bispecific therapy from its partner Johnson & Johnson—Legend Biotech maintains confidence in its CAR-T therapy, citing the unique benefits of a one-time infusion.
A market vast enough for diverse treatment options
In its latest earnings call, Legend Biotech executives expressed optimism regarding Carvykti’s future. Although Tecvayli recently secured fast FDA approval for both combination and solo regimens with competitive clinical data, Legend believes the multiple myeloma market remains largely untapped.
Currently, BCMA-targeting modalities account for only about 5% of the market share in the second-to-fourth-line settings in the U.S. With over 100,000 patients worldwide undergoing second-line treatment, Legend asserts there is ample room for both Carvykti and Tecvayli to thrive as they replace older standards of care.
Competitive edge: One-time infusion and long-term remission
Legend highlighted several factors underpinning Carvykti’s strategic advantage:
-
Unique Value Proposition: As a one-time treatment, it offers patients years of treatment-free remission, providing significant quality-of-life benefits and payer savings compared to continuous therapies.
-
Sequencing Strategy: Clinical guidelines suggest that positioning CAR-T in earlier lines of treatment is more effective, as prior exposure to bispecific agents might diminish the efficacy of subsequent CAR-T cell therapy.
-
Manufacturing Excellence: The company’s manufacturing success rate has climbed to 99%, supporting J&J and Legend’s plans to scale the product toward a $5 billion peak annual sales potential.
Strong financial performance
2025 was a landmark year for Legend, with revenue reaching $1.03 billion, a 64% year-over-year increase. Global sales for Carvykti totaled $1.9 billion for the year. Starting 2026 with $949 million in cash, Legend reported that Carvykti became profitable in 2025 and expects the entire company to achieve profitability this year.