FDA approves the first CAR-T cell therapy, idecabtagene vicleucel for the multiple myeloma patients

March 29, 2021

On March 26, 2021, the FDA has granted an approval to idecabtagene vicleucel (ide-cel; Abecma) for multiple myeloma (MM) patients whose cancer has been progressed even after 4 or more lines of treatments.

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Ide-cel is the first approved chimeric antigen -receptor (CAR) - T cell therapy for MM patients and made to target the protein called BCMA (B-cell maturation antigen) in MM cancer cells.    

This approval was based on the phase 2 KarMMa trial (NCT 03361748), in which 72% of patients responded to the drug.  The response to the drug was rapid and lasted for median 11 months.  Among those who completely responded to the drug (28%), 18 patients (65%) showed the remission of the diseases at least for 1 year.    

Ide-cel can cause serious cytokine release syndrome (CRS), neurologic toxicities, hemophagocytic lymphohistiocytosis(HLH)/macrophage activation syndrome (MAS), and prolonged cytopenia which can be fatal.  Other most common side effects are infection, pneumonia, general physical deterioration, febrile neutropenia.

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After the approval of Melphalan flufenamide, the approval of Ide-cel is such great news for the MM patients who have no further option. 

CAR-T cell therapy has been truly transformational for cancer care, especially for patients with blood cancer.  What CAR-T cell therapy would bring for the cancer patients in the future?  I, for one, cannot wait to see.