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

This could be a gamechanger!!!

[Note: this is a recycle from 2023]

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, as these therapies all use the same technology and supply chain processes! You can learn more on the topic below.

[note: this is in the archives, so there is a paywall, but it is not essential to read to get the most out of this post]

COVID SUPPLY CHAINS: FACT NOT FICTION—CHAPTER 3

The article goes on: T-cell malignancies have occurred in patients treated with several products in the class. The FDA notes that all gene therapy products involving integrating vectors (lentiviral or retroviral vectors) come with the potential risk of developing secondary malignancies. Thus, they are labeled as a class warning in the U.S. prescribing information (USPIs) for approved BCMA-directed and CD19-directed genetically modified autologous T cell immunotherapies.

One of the products under investigation is Novartis’ Kymriah, approved by FDA in August 2017. The active ingredient (lentiviral vector) is manufactured by Oxford Biomedica, a company I have reported on many times, since they also manufacture(d) the AstraZeneca injections, see:

[note: this is in the archives, so there is a paywall, but it is not essential to read to get the most out of this post]

Room for optimism?

If these go down after FDA investigation, gene therapy does too. The side effects of these products have been around neurological toxicities and cytokine release syndrome (cytokine storm)—now we have accounts of T-cell malignancies—is it coincidental that turbo cancers are being reported by honest doctors?

I’ll keep a close eye on this and let you know if further revelations turn up.

[Note: still optimistic the truth will out, eventually]