US FDA approves ciltacabtagene autoleucel (CARVYKTI) for relapsed or refractory myeloma

The US Food and Drug Administration (FDA) has approved the CAR-T treatment ciltacabtagene autoleucel (also known as cilta-cel and marketed as Carvykti). Manufactured by Janssen, it is specifically approved for the treatment of patients with relapsed or refractory myeloma after four or more prior lines of therapy, including a proteasome inhibitor (like bortezomib), an immunomodulatory agent (like lenalidomide), and an anti-CD38 monoclonal antibody (like daratumumab or isatuximab). You can find the full Janssen press release…