CGTLive’s Weekly Rewind – August 18, 2023

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. No AdComm Meeting for Sickle Cell Therapy Lovo-Cel

Bluebird's gene-edited cell therapy has a PDUFA date of December 20, 2023.

2. David Boyer, MD, on Potential Advantages of Suprachoroidal Gene Therapy for Neovascular AMD

The senior partner at Retina Vitreous Associates Medical Group discussed new findings from the AAVIATE study of RGX-314.

3. FDA Places Formal Clinical Hold On 2seventy bio's Trial for Acute Myeloid Leukemia CAR-T In Relation to Patient Death

The formal hold comes approximately 2 months after Seattle Children’s paused the trial in accordance with the clinical study protocol stopping rules.

4. Dilsher Dhoot, MD, On Reducing Treatment Burden in Diabetic Retinopathy With Gene Therapy

The adjunct clinical assistant professor, ophthalmology, Keck School of Medicine, University of Southern California discussed unmet needs with the current treatment landscape for DR.

5. FDA Lifts Partial Clinical Hold on Arcellx’s Trial for Multiple Myeloma CAR-T CART-ddBCMA

The partial clinical hold was originally placed in June 2023 in relation to the death of a patient participating in the trial.