Johnson & Johnson and Legend Biotech’s Carvykti maintains growth in the multiple myeloma market despite the emergence of a more convenient alternative. The drug’s sales surged to $117 million in the second quarter from $72 million in the preceding three months, indicating successful efforts to bolster its supply.
Carvykti’s performance has been hindered by limited manufacturing capacity since its launch in the past Spring. The partners are now focused on expanding production to tap into earlier lines of treatment. The FDA has scheduled April 5, 2024, for the decision on Carvykti’s application as a second- to fourth-line myeloma therapy.
Though the standard review timeline is longer than anticipated, the demand for Carvykti surpasses the supply. RBC Capital Markets analysts suggest the extended timeline is unlikely to pose a major problem.
While the FDA approved J&J’s Tecvayli for late-line myeloma treatment, doctors are predominantly using bispecifics like Tecvayli as a bridging therapy while patients await CAR-T treatment. Commercial insurers continue to reimburse for Carvykti post-Tecvayli treatment.
Despite not being FDA-approved for earlier uses, off-label use of CAR-T therapy is growing, especially in high-risk relapse cases. Approximately 15% to 20% of second-line patients are considered high risk.
With production scaling up and demand robust, Carvykti is narrowing the gap with Bristol Myers Squibb’s Abecma, the first-to-market option. In Q2, Abecma generated $132 million in sales, slightly down from the previous quarter. Abecma is projected to slide further in Q3 due to planned manufacturing maintenance.
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Legend’s approach to maintaining facility operations during maintenance is through a rotation strategy, ensuring minimal disruption. Carvykti’s advantages include its operational flexibility in outpatient settings compared to Abecma.
However, Carvykti has encountered more manufacturing out-of-specification cases than its competitor Abecma. J&J and Legend are requesting the FDA to expand Carvykti’s manufacturing standards, aiming to reduce the out-of-spec rate.
To enhance supply, Legend plans to open a factory in Belgium by the end of 2023. This facility will initially cater to clinical supply for the CARTITUDE-6 trial, examining Carvykti’s efficacy in newly diagnosed myeloma patients following standard combination therapy.
As the landscape of myeloma treatment evolves, Carvykti’s growth trajectory continues, demonstrating its significance in addressing the needs of patients facing this challenging disease.
