CGTLive®’s Weekly Rewind – July 4, 2025

CGTLive®’s Weekly Rewind

Welcome to CGTLive®’s Weekly Rewind! We’ve compiled 5 highlights from this week’s coverage of advances in gene and cell therapies, including FDA actions, notable research, and interviews with experts across the field.

1. Survival Outcomes Found to Be Comparable for Axi-Cel, Liso-Cel, and Tisa-Cel in Real World DLBCL Data

The 3 FDA-approved CAR T-cell therapies showed comparable survival outcomes in DLBCL over a 3-year period.

2. Considerations for β-Thalassemia Gene Therapy in the Real World

Tami John, MD, a clinical associate professor at Stanford Medicine, discussed considerations for using beti-cel and exa-cel for TDT in the clinic.

3. Rocket Snags IND Clearance for BAG3-DCM Gene Therapy Trial

The IND clearance enables the company to start a first-in-human phase 1 clinical trial for the gene therapy.

4. FDA Drops REMS Requirement for 6 Approved CAR T-Cell Therapies

The FDA made the move with the view that the REMS are no longer necessary to ensure a favorable risk-benefit-ratio for the products and that dropping the requirement may increase accessibility to these therapies.

5. FDA Activity Recap: June 2025 Features New Platform Designation, IND Clearance, and More

Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team.