Europa Perspectives: EMA Transparency in Investigating CAR-T Secondary Cancers

In a Jan. 25, 2024 interview, Chris Spivey, editorial director, Pharmaceutical Technology® and BioPharm lnternational®, spoke with Steffen Thirstrup, MD, PhD, chief medical officer, European Medicines Agency (EMA), for the Europa Perspectives series. In this third installment, Thirstrup emphasizes the importance of transparency in investigating potential safety issues, such as secondary cancers linked to certain chimeric antigen receptor T cell (CAR-T) therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders. Full the interview transcript, click here.

This segment of discussion focuses specifically on warning labels for secondary cancers, recently applied to some CAR-T therapies. Thirstrup says, “[It’s] an area for a regulator to consider, or be aware of, or at least to understand. But I think it’s unavoidable if we, as regulators, pick up a signal that might be a potential signal of a safety issue with a product or classes of products that we have approved, we need to investigate that. But we are also obliged to be transparent towards developers, patients, all stakeholders that we are investigating this and ultimately explaining the conclusion of that investigation. So, whether there’s something or not—and as you can see in what’s been published around CAR T cells and secondary cancer—I think that’s what you’re alluding to, that’s a signal we are investigating as well. We also know that patients with cancer get secondary cancers. So, the challenge is again to disentangle the hen and the egg question, more or less. I think it’s important for us to be transparent, and we have no interest in … putting a black thumb on any of those products. But on the other hand, we need to be transparent. We owe this to the community, we owe this to the patients, and we are a public body, so we cannot hide what we’re doing. We don’t have any interest in hiding what we’re doing. That would be more devastating than being transparent.”

Thirstrup is a medical doctor with a PhD in pharmacology and broad clinical experience in general internal medicine. He has a track record of working with the European Union regulatory network. He previously led the Division for Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority and was the Danish member of EMA’s human medicines committee (CHMP). He was also a member of EMA’s Committee for Advanced Therapies (CAT), the chairperson of the CHMP’s Respiratory Drafting Group and co-chair of the European Commission Working Group on Market Access of Biosimilars.