MFDS Approves 'Kavictyju', CAR-T Therapy for Multiple Myeloma

The Ministry of Food and Drug Safety announced on the 17th that it has approved 'Karbicti (ciltacabtagene autoleucel)', a chimeric antigen receptor T-cell (CAR-T) therapy for multiple myeloma developed by Korea Janssen, a rare drug.

Mechanism of action of Cavicti.

Karbicti is an anticancer drug that inserts genetic information enabling the patient's immune cells to recognize B-cell maturation antigen, then reinfuses these T cells back into the patient's body.

It is expected to provide a new treatment opportunity for patients with relapsed or refractory multiple myeloma who have previously undergone at least four treatments, including ▲proteasome inhibitors ▲immunomodulatory drugs ▲anti-CD38 antibodies.

Karbicti is designated as a 'long-term follow-up' drug, requiring adverse event monitoring for 15 years from the date of administration. The Ministry of Food and Drug Safety stated, "In accordance with the review standards set by the Advanced Regenerative Bio Act, we have scientifically and thoroughly reviewed and evaluated the quality, safety and efficacy, manufacturing, and quality control standards of this drug."