ISCT responds to FDA report on CAR-T risk of T-cell malignancy

The International Society for Cell and Gene Therapy (ISCT) has announced the publication in Nature Medicine of a commentary addressing a statement from the US Food and Drug Administration (FDA) that it is investigating serious risk of T-cell malignancy in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapy.

ISCT, the global society of clinicians, researchers, regulators, technologists and industry partners dedicated to the translation of cell and gene therapy (CGT) into safe and effective therapies to improve patients' lives, says that it aligns with the FDA in support of the need for thorough investigation and transparency.

"... premature to establish the magnitude of what appears to be a very low risk"But the society has also stressed that it firmly agrees that the benefits of CAR-T therapies continue to outweigh potential risks in the vast majority of cases and recommends that centers with cell therapy expertise should continue to make commercial products available to patients when it appears to be the best option available.