ISCT in the News

In Draft Guidance for Cell and Gene Therapy Industry, FDA Broadens its Approach to Product Potency

Jan 19, 2024 | By Caroline Hopkins

In the last days of 2023, the US Food and Drug Administration put out a draft guidance meant to better support drugmakers' efforts to bring novel cell and gene therapies to market.

Experts Comment on FDA Report on Risk of T-Cell Malignancy

Jan 10, 2024

The International Society for Cell & Gene Therapy (ISCT) has announced the publication in Nature Medicine of an expert consortium commentary addressing a recent statement from the US Food & 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. 

CAR T Cell Therapy Is a Comparatively Low-Risk Cancer Treatment: Industry Experts

Jan 9, 2024 | By Heather McKenzie

CAR T cell therapy is lower risk than other cancer treatments, according to a prominent group of cancer and cell therapy leaders who published their commentary in Nature Tuesday, a little more than a month after the FDA announced it was investigating the “serious risk” of T cell malignancies in patients who received such treatments. But more information is still needed, the authors stressed.

Cell Therapy Bigwigs Endorse CAR-T in Nature Medicine Article Amid FDA Safety Probe

Jan 9, 2024 | By Angus Liu

As an FDA investigation into patients developing secondary T-cell cancers rocked the CAR-T world, a group of cell therapy experts, including CAR-T pioneers Bruce Levine, Ph.D., and Carl June, M.D., are lending their support to the emerging immunotherapy in a commentary published in Nature Medicine.

ISCT Leads Global Scientific Consortia to Respond to Recent FDA Report on Risk of T-Cell Malignancy in Patients Following CAR T-Cell Immunotherapies

Jan 9, 2024

The International Society for Cell & Gene Therapy (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, today announces the publication in Nature Medicine of an expert consortium commentary addressing a recent statement from the U.S. Food & 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 ' Unanswered questions following reports of secondary malignancies after CAR-T cell therapy'.

Cell Therapy Research Consortia Responds to FDA's CAR T-Cell Therapy Warning

Jan 9, 2024

The International Society for Cell and Gene Therapy (ISCT) on Tuesday published a commentary in Nature Medicine  in response to the US Food and Drug Administration's announcement that it would investigate the risk of T-cell malignancy in patients treated with BCMA- or CD19-directed autologous CAR T-cell immunotherapy.