Tanja Obradovic, Senior Advisor of Oncology Drug Development at HopeAI, Consultant, Oncology Drug Development at Arc Nouvel Clinical Development Consulting, and Oncology Medical Strategy Advisor at Mercurial AI, shared a post on LinkedIn:
“New CAR-T cell cancer therapy will be required to demonstrate superiority over existing CAR-Ts or relevant standard of care through a control group in randomized controlled clinical trial if seeking FDA approval.
This is the message FDA delivered just few days ago in commentary published in JAMA.
This new FDA policy will have a high impact on clinical development strategy of new CAR-Ts. There are currently seven CAR-Ts approved, all of which were brought to market based on data from single-arm trials without a control group.
Ongoing Phase IIIs that have control arms (such as several by Bristol Myers Squibb, Gilead Sciences, and Lyell Immunopharma) will avoid impact but many Biotech and Pharma players who were planing to seek approvals based on uncontrolled ongoing or planned CAR-T trials will have to make thoughtful decisions on proper design in order to manage costs and time-line.
This new FDA approach is certainly going to bring clarity to increasingly frequent questions by both practitioners and patients on which CAR-T product is better in terms of safety and efficacy considering lack of head-to-head comparison in the randomized trial.”
Title: Evidence-Based Trial Design for Chimeric Antigen Receptor T-Cell Therapy in Oncology
Authors: Upendra Mahat, Asha Das, Vijay Kumar, Vinay Prasad
You can read the full article in JAMA Network.
Read more about FDA Approvals on OncoDaily.