Regulatory J&J Files For Approval of Carvykti in Europe

J&J Files For Approval of Carvykti in Europe


Johnson & Johnson has reached another milestone in their competition with Bristol-Myers Squibb to develop cell treatments that can treat people who have multiple myeloma at an earlier point in the disease’s progression.

Carvykti (cilta-cel) is a treatment for patients who have lenalidomide-refractory and relapsed multiple myeloma. J&J and co-developer Legend Biotech have submitted an application for authorization of Carvykti to the European Medicines Agency (EMA). The CAR-T therapy, which was just licensed for usage in the fifth line of treatment in the U.S. and Europe a year ago, has shown promise as a therapy for patients in the second line.

Carvykti might overtake BMS’s CAR-T Abecma, which was also authorized by the FDA in March 2021 for fifth-line usage, if the application is successful in receiving approval.

Edmond Chan, M.D., who serves as the therapeutic area lead for hematology for Janssen, stated, “Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy earlier in their treatment journey. If approved, this will be the first and only CAR-T therapy available to treat relapsed and refractory multiple myeloma patients as early as second line.”

The application that was submitted by J&J is predicated on the findings of the phase 3 CARTITUDE-4 research, which are scheduled to be presented on June 5 at the annual conference of the American Society of Clinical Oncology (ASCO) in Chicago.

An abstract from the trial was posted online around a month ago, and it suggested that a single infusion of Carvykti reduced the chance of tumor progression or mortality by nearly 75% compared to the standard of care among patients with multiple myeloma who had previously attempted one to three treatment lines. Carvykti was shown to cut the chance of mortality by 22%, although it must be noted that the data was still in its earliest stages.

In spite of the excitement surrounding these treatments, the limited production capacity has prevented widespread use in the real world. For example, Johnson & Johnson recently made the decision to delay the introduction of Carvykti in the United Kingdom due to shortages in its manufacturing network. A spokesperson for J&J said at the time that the company wasn’t in a position to introduce the drug in the U.K. However, he did confirm that the clinical trial program would go through as initially planned.

BMS, for its part, has participated in a phase 3 trial of Abecma in an effort to broaden the application of the drug. In patients who had gone through two to four phases of therapy, the company reported that Abecma cut the probability of the tumor progressing or dying by 51%. This announcement was made around five months ago.

The results of the trial were positive; nevertheless, the American Society of Hematology (ASH) did not accept the data for presentation at the organization’s annual conference.

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