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What t-cell redirecting therapies have beed FDA approved? What are there indications?

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• July 4, 2025

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This video will cover the FDA approves t-cell redirecting therapies and what thier indications are. 

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Transcript

What T-cell redirecting therapies have been FDA approved? What are their indications?

So now there are, as we speak, there are five that are approved by the FDA two that are Car-T cells, which are ide-cel or ABECMA and cilta-cel or CARVYKTI. And there are three that are bispecific T-cell engages. one is called teclistamab, the other called elrenatamab.

They're both BCmA directed therapy. So the protein they're recognizing on the surface of the cancer cell is called BCmA, which is stands for B-cell maturation antigen, which is the same protein. The same antigen recognized by the two approved Car-T cells. And we have one bispecific that is so far the only therapy, of T-cell engages, that recognizes a different protein.

And that's called talquestamab. They recognize a protein called GPRC5D. As we speak, the three T cell engagers, teclistamab, elrenatamab, and talquetamab, are approved in the US for patients who have relapsed or refractory myeloma, who have received four prior lines of therapy, and the CAR-Ts, because they started development early, they have received very recently an approval to be used even earlier.

So in the case of cilta-cel or CARVYKTI, it’s approved for patients with myeloma with relapsed disease who have received at least one line of therapy. That includes and the disease is refractory to lenalidomide. in the case of ide-cell, it's a proof or ABECMA is approved for patients who have received two or more therapies, and the disease has been exposed to an immunomodulatory agent like revlimid, a proteasome inhibitor like velcade, and an anti CD 38 monoclonal antibody.