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. Pre-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.
4. Infusion of Carvykti – You may be given medicines to prevent or lessen a possible allergic reaction to Carvykti and to reduce fever. You will then receive your one-time infusion of Carvykti T cells through an intravenous catheter (tube). The infusion takes approximately 30 to 60 minutes. After the infusion, the genetically modified T cells will begin to seek out your myeloma cells and attack them.
5. Monitoring – Your doctor will monitor you for at least 10 days to observe that your treatment is working, and to check for any signs or symptoms of side effects. Blood tests will track your progress. You must stay close to the center where you receive your treatment for at least 4 weeks, and make a plan with your doctor for long-term follow-up.
Important safety information
Carvykti may cause side effects that are severe or life-threatening. Immediately contact your doctor or get emergency medical care if you experience any of the following:
¡ fever of 100.4°F/38°C or higher,
¡ chills or shivering,
¡ fast or irregular heartbeat,
¡ difficulty breathing, shortness of breath,
¡ very low blood pressure,
¡ dizziness or lightheadedness,
¡ effects on your nervous system, which may be subtle and can occur weeks after your infusion of Carvykti.
The most common side effects that occurred in more than 20% of myeloma patients who received Carvykti in the clinical trial setting are fever, cytokine release syndrome (CRS), hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, pathogen-unspecified infections, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspneodeficiency virus (HIV) test result by some commercial tests, even when you may be HIV-negative.
Support
The MyCARVYKTI® Patient Support Program helps eligible patients who are receiving Carvykti, as well as their care partners, with transportation, lodging, and out-of-pocket costs related to meals and other travel expenses associated with Carvykti immunotherapy. Call 1.800.559.7875.
myeloma.org Visit myeloma.org to learn more about Carvykti as well as other myeloma therapies. As always, the IMF urges you to discuss all medical issues with your doctor and to contact the IMF InfoLine with your myeloma-related questions and concerns at 1.818.487.7455 or InfoLine@myelomaorg .