Regulators in the U.S. and Europe have approved updates to the prescribing information for Carvykti (ciltacabtagene autoleucel), a cell therapy used to treat hard-to-manage myeloma.
The updates include survival data from the ongoing CARTITUDE-4 (NCT04181827) Phase 3 clinical trial. This study compares Carvykti with standard myeloma treatments in people who have received one to three prior lines of therapy. The data include more than 400 people, followed for a median of nearly three years. During that time, Carvykti showed a 45% lower risk of death compared with standard care.
“Carvykti remains the market leader in multiple myeloma CAR-T as the only approved therapy for second-line treatment, now with a survival benefit label,” Ying Huang, PhD, CEO of Legend Biotech, said in a company press release.
Therapy uses engineered immune cells to target cancer
Legend developed Carvykti in collaboration with Johnson & Johnson Innovative Medicine. The companies recently launched a Phase 2 study called CARTITUDE-10 (NCT07149857) to test Carvykti in people newly diagnosed with myeloma. That trial is actively recruiting participants at sites in the U.S., Spain, and Australia.
Carvykti is an autologous CAR T-cell therapy. This treatment works by collecting a patient’s immune cells, engineering them to better recognize and attack cancer cells, and infusing them back into the body. It is approved in the U.S. for adults with relapsed or refractory multiple myeloma whose disease is resistant to Revlimid (lenalidomide) and who have received at least one line of therapy that included an immunomodulatory agent and a proteasome inhibitor. It has a similar approval in the EU.
Carvykti’s approvals were supported by results from the Phase 3 CARTITUDE-4 study and the earlier Phase 1/2 CARTITUDE-1 study (NCT03548207). Recent long-term data from that study showed a median survival time of nearly five years after one infusion of Carvykti, with approximately one-third of patients alive and free from disease progression at the latest follow-up.
Legend reports that more than 9,000 people worldwide have now received Carvykti. The company recently began manufacturing the therapy at a site in Belgium to help expand access in Europe. Carvykti generated $524 million in total net sales in the third quarter of this year, according to the company.
“Carvykti continues to deliver strong sequential revenue growth, driven by sustained demand and recognition of its unprecedented survival benefit, now supported by five-year progression free data from the CARTITUDE-1 study,” Huang said, adding that Legend is “poised to achieve Carvykti profitability by year-end and company-wide profitability in 2026.”
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