FDA approves second CAR T-cell therapy for multiple myeloma

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

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.