FDA Reports Hospitalizations & Deaths Linked to CAR-T Cell Immunotherapies: Potential for Imminent Regulatory Action

This could be a gamechanger!!!

TrialSite News drops a bombshell

This article below drew my attention last week. Having just circled back and read it again, it could be a gamechanger:

FDA Reports Hospitalizations & Deaths Linked to CAR-T Cell Immunotherapies: Potential for Imminent Regulatory Action

I’ve picked out the salient points so that subscribers to Inside Pharma can get the picture. I think also a couple of articles are free to view before the paywall kicks in.

Anyway, here are a few snippets:

The Food and Drug Administration (FDA) reports receiving accounts of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or post marketing adverse event (AE) data sources. The FDA reports hospitalization and deaths and potentially an imminent need for regulatory action.

Imminent need for regulatory action?

Action would blow the whole gene therapy hoax…