FDA's Process of Defining Product Classes and Risk Concern Alignment

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials. 

In today’s episode, Fierce Pharma’s Angus Liu talks with regulatory experts Mwango Kashoki, M.D., SVP, Global Head of Regulatory Strategy at Parexel, and Steve Winitsky, M.D., VP, Technical, Regulatory Strategy at Parexel, to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T candidates and their developers down the line.  

To learn more about the topics in this episode: 

• FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe
• Amid high-profile CAR-T safety probe, FDA’s Peter Marks offers first glimpse at data under review

See omnystudio.com/listener for privacy information.