FDA approves 1st T-cell receptor therapy for cancer

The FDA approved afamitresgene autoleucel, or afami-cel (Tecelra), as the first T-cell receptor therapy for cancer.

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Afami-cel is made by collecting a patient’s T-cells, genetically modifying them and infusing them back into the patient, according to an Aug. 27 National Cancer Institute news release. The treatment has been approved for people with metastatic synovial sarcoma who have been treated with chemotherapy and whose tumors are positive for the presence of MAGE-A4 and a certain HLA proteins.

In a trial of 44 patients, 43% saw a shrinkage in their tumors that lasted an average of six months.

This T-cell therapy is similar to CAR-T cell therapies already approved by the FDA, according to the release.

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