FDA approves second CAR T-cell therapy for multiple myeloma

Mar 02, 2022
Devin Golden

Nearly one year ago, the U.S. Food and Drug Administration (FDA) approved the first CAR T-cell therapy for multiple myeloma.

Almost 11 months to the date, a second CAR T-cell therapy received the FDA’s endorsement.

The FDA approved the cancer cell and gene therapy Carvykti ® (ciltacabtagene autoleucel) for difficult-to-treat cases of multiple myeloma. Janssen, a subsidiary of Johnson & Johnson, one of the therapy’s manufacturers, announced the news Monday, February 28, 2022, on the company’s website. The therapy is now available to patients after four unsuccessful attempts at using other therapies.

Carvykti, also called by its shortened generic name cilta-cel, is the sixth CAR T-cell therapy backed by the FDA for any kind of cancer. All six are approved for types of blood cancer, which includes multiple myeloma. ABECMA® (idecabtagene vicleucel) was the first CAR T-cell therapy approved for this cancer, which forms from plasma cells.

How Carvykti treats multiple myeloma

Carvykti is a CAR T-cell therapy. Doctors remove patients’ T cells and add genetic code to the cells, which are strengthened to look for multiple myeloma cells. CAR stands for chimeric antigen receptor. T cells, a type of white blood cell, are part of the immune system helping to protect the body from infection. The antigen receptor is the added enhancement the T cells need to seek out cancer cells more effectively.

In a recent clinical trial of 97 multiple myeloma patients, Carvykti led to a 74% two-year survival rate and 98% objective response rate, the latter figure meaning nearly every patient had their tumor either stop growing or shrink. This trial’s success instilled confidence in the FDA to approve the therapy for the blood cancer.

Carvykti is the second FDA approval of a type of gene therapy in 2022. A month ago, the agency approved a T-cell receptor therapy for a rare type of melanoma forming in the eye.

Alliance for Cancer Gene Therapy has promoted CAR T-cell therapy and other cancer cell and gene therapies for more than two decades. Our efforts helped fund breakthrough research to create the first effective CAR T-cell therapy for any type of cancer.

Please consider donating to the Alliance to help us develop other cell and gene therapies like Carvykti, adding more options for patients with resistant or stubborn cancers.

Page sources

  1. FDA Approves Cilta-cel to Treat R/R Multiple Myeloma. American Journal of Managed Care. Retrieved from: https://www.ajmc.com/view/fda-approves-cilta-cel-to-treat-r-r-multiple-myeloma. Accessed: 03/01/2022.
  2. U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. Janssen. Retrieved from: https://www.janssen.com/us-fda-approves-carvykti-ciltacabtagene-autoleucel-janssens-first-cell-therapy-bcma-directed-car-t. Accessed: 03/01/2022.