CARVYKTI®
(ciltacabtagene autoleucel) Carvykti was approved by the U.S. Food and Drug Administration (FDA) in February 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 4 prior lines of therapy. In April 2024, the FDA expanded the approval of Carvykti to patients with RRMM who have received at least 1 prior line of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The expanded approval of Carvykti makes this important chimeric antigen receptor (CAR) T-cell therapy available to patients earlier in their treatment journey. In addition, Carvykti continues to be studied in earlier-line treatment settings, including in newly diagnosed myeloma.
How Carvykti works
Carvykti is a personalized immunotherapy delivered as a onetime infusion, manufactured using the patient’s own white blood cells (T-cells) that have been genetically modified to recognize and attack BCMA, a protein that is nearly universally expressed on the surface of myeloma cells. This leads to the death of BCMA-expressing myeloma cells.
How Carvykti is given
The treatment process with Carvykti generally takes 2 to 3 months and is comprised of the following five steps: 1. Leukapheresis – Your blood is drawn, then passed through a machine that separates it into its individual components. The white blood cells are collected, and the remaining blood components are then immediately re-infused back into your bloodstream. This process may take 3 to 6 hours. 2. Modification of T cells – Your white blood cells are sent to a laboratory where your T cells are separated out, then genetically modified to make Carvykti. Making your Carvykti CAR T cells takes approximately 4 to 5 weeks. 3. P re-infusion chemotherapy – While your Carvykti is being made, you may receive chemotherapy to treat your myeloma. Then, for the 3 days prior to your infusion of Carvykti, your doctor will give you chemotherapy to help prepare your body to receive the infusion of the genetically modified T cells.