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FDA’s Recent Approval of 2 CAR T-Cell Therapies a ‘Big Step Toward’ Long-Term Control of Myeloma for More Patients

The FDA has approved cilta-cel (Carvykti™) and ide-cel (Abecma®) for earlier treatment of multiple myeloma.

Rye Brook, N.Y., April 16, 2024 – The U.S. Food and Drug Administration (FDA) recently approved the CAR T-cell therapies ciltacabtagene autoleucel (cilta-cel; Carvykti™) and idecabtagene vicleucel (ide-cel; Abecma®) for earlier treatment of adults with multiple myeloma. 

Prior to these approvals, patients had to receive at least four lines of treatment before they were eligible for CAR T-cell therapy.

“CAR T-cell therapy has come a long way since LLS funded the very earliest studies leading to these landmark treatments,” says Lee Greenberger, Ph.D., LLS Chief Scientific Officer. “These approvals mark the fourteenth and fifteenth approvals for CAR-T since the first in 2017. These approvals are a big step toward better long-term control of multiple myeloma for more patients.” 

Cilta-cel is now approved for use after just one prior line of therapy, which includes some of the most used treatments for myeloma such as a proteosome inhibitor like bortezomib (Velcade®) and an immunomodulator drug like lenalidomide (Revlimid®).

Ide-cel is now approved for use in patients who received at least two prior lines of treatment, including a proteosome inhibitor, an immunomodulator and an anti-CD38 antibody like daratumumab (Darzalex®) or isatuximab (Sarclisa®), which can be used in combination with one another.

KarMMa-3 and CARTITUDE-4 Data Lead to Approvals 

In the CARTITUDE-4 study, treatment with cilta-cel reduced the risk of multiple myeloma progression and death by 59% compared to standard therapies. The median time before the disease progressed was 11.8 months in patients receiving standard therapies, but the median time for patients on cilta-cel was 16 months and still counting at last report.

In KarMMA-3, ide-cel tripled progression-free survival time compared to standard treatments, from 4.4 months to 13.3 months. Most patients (71%) treated with ide-cel responded to treatment and 39% had a complete response, which means no cancer could be detected. The response in these patients lasted for a median of 20 months.

CAR T-cell Therapy Helps the Immune System Target Cancer Cells

CAR T-cell therapies are personalized treatments that work by reprogramming a patient’s own T-cells to seek out and preferentially kill cancer cells. 

Both cilta-cel and ide-cel target a protein called BCMA that is common on myeloma cells but uncommon on other cells, reducing the odds that treatment will kill healthy cells. Another benefit of CAR T-cell therapy is that it is generally given just once and can lead to durable responses, while most other treatments must be taken regularly for as long as they work.

With at least 35,000 new diagnoses each year and more than 170,000 Americans living with myeloma, there is a real need to provide new treatment options for people at all stages of the illness. 

“LLS is working hard to find and fund the most promising research so that we can discover new treatments, and new ways to use existing treatments, in every person with every type of blood cancer,” says Dr. Greenberger. “We have a particular focus on finding ways to improve CAR T-cell therapy, both in terms of effectiveness and availability, so even more people can benefit.”

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Media Contact:
Ryan McDonald
Senior Manager, Medical and Science Communications