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Autolus’s Obe-cel Receives FDA RMAT Designation; JNJ / Legend Update Carvykti’s HCP Website

Here is a brief preview of this blast: On Monday, April 25, 2022, Autolus announced (press release) that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel (AUTO1; autologous CD19 CAR-T) for adult r/r B-ALL. On the same day, Carvykti’s (JNJ / Legend’s autologous BCMA CAR-T) HCP website was updated to include onboarded treatment centers and additional product messaging (Carvykti HCP website). Below, Celltelligence provides insights on how RMAT designation may accelerate obe-cel's regulatory pathway, while analyzing Carvykti’s updated HCP website.

About The Author

Mark McCully, PhD

Senior Content Lead
Mark McCully, PhD is the Content Lead for Celltelligence covering the dynamic and rapidly evolving cell therapy space. Mark regularly attends large and small cell therapy scientific meetings to build upon his decade of oncology R&D experience. To that end, Mark previously worked on numerous consulting projects for large cap pharma and emerging biotech to help characterize the ever-changing landscape.