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Janssen, Legend Biotech's Carvykti Nets EU Approval in Early-Line Multiple Myeloma

NEW YORK – Janssen said Monday that the European Commission approved its BCMA-directed CAR T-cell therapy Carvykti (ciltacabtagene autoleucel) as an early-line treatment for relapsed or refractory multiple myeloma patients.

The EC approved the indication after reviewing results from the Phase III CARTITUDE-4 trial in which patients treated with Carvykti had a significantly reduced risk of disease progression or death compared to those on standard-of-care therapy at a median follow-up time of 15.9 months. The study included more than 400 patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. Median progression-free survival was 11.8 months in the standard-of-care arm and was not reached in the Carvykti arm.

At 12 months, 76 percent of Carvykti-treated patients had not yet experienced disease progression, compared with 49 percent in the control arm. In the Carvykti arm, 61 percent of patients were minimal residual disease-negative, versus 16 percent of those who received standard therapy. Overall survival data were not mature at the time of the data submission, but Janssen, a Johnson & Johnson subsidiary, said the trend favored Carvykti.

To be eligible under the EC approval for treatment with Carvykti, which Janssen developed with Legend Biotech, patients must have received at least one prior therapy, such as an immunomodulatory agent or a proteasome inhibitor; demonstrated disease progression on the prior therapy; and be refractory to Bristol Myers Squibb's Revlimid (lenalidomide).

"Patients with [Revlimid]-refractory multiple myeloma tend to experience early resistance to standard treatments and their disease worsens exponentially with each additional line of therapy," Jesús San Miguel, director of clinical and translational medicine at Universidad de Navarra in Spain, said in a statement. "A single infusion of [Carvykti] has been shown to significantly lower the risk of progression or death compared to current treatment options, as early as after first relapse."

Earlier this month, the US Food and Drug Administration approved Carvykti in the same setting. The product has already been approved in the US and Europe for patients who have failed many previous lines of therapy. Bristol Myers Squibb and 2seventy Bio's BCMA-directed CAR T-cell therapy Abecma (idecabtagene vicleucel) is also approved for earlier-line use in refractory multiple myeloma in the European Union, US, Japan, and Switzerland.