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FDA Approves CARVYKTI® First-of-its-Kind CAR-T Therapy for Second-Line Multiple Myeloma

Legend Biotech's CARVYKTI® (ciltacabtagene autoleucel) has received FDA approval for treating relapsed or refractory multiple myeloma in patients who have tried at least one proteasome inhibitor and one immunomodulatory drug and are no longer benefiting from lenalidomide.

CARVYKTI® (ciltacabtagene autoleucel) is a cutting-edge treatment for multiple myeloma, a cancer of the bone marrow's plasma cells.

This therapy, developed by Bristol Myers Squibb and bluebird bio, is used when other treatments haven't worked, especially for patients who have already tried at least one previous therapy.

Here’s how it works: First, doctors take some of the patient’s T cells (a type of immune cell) from their blood. These cells are then modified in a lab to recognize and attack myeloma cells.

The modification involves adding a special receptor called CAR (chimeric antigen receptor) that targets a protein on the surface of the cancer cells called BCMA (B-cell maturation antigen).

After the T cells are engineered and multiplied, they are infused back into the patient’s bloodstream. These new, modified cells then hunt down and destroy the cancer cells.

CARVYKTI® has shown encouraging results, with many patients experiencing significant and long-lasting responses. However, it’s not without risks.

Potential side effects include Cytokine Release Syndrome (CRS), which is an immune reaction that can cause fever and other symptoms, and neurological issues like confusion or seizures.

Because of these risks, patients need close monitoring during and after treatment.

The treatment offers a new and promising option for people with multiple myeloma who haven’t had success with other treatments, giving them a chance for extended periods of remission and a better quality of life.