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Kymriah Receives FDA Approval for R/R FL After Two or More Lines of Systemic Therapy

Here is a brief preview of this blast: Late on Friday, May 27, Novartis announced (press release) that the FDA granted accelerated approval for Kymriah (CD19 CAR-T) in ≥3L r/r FL. Kymriah is the second CAR-T to be approved by the FDA in r/r FL. Of note, Kymriah’s FDA approval was based on results from the Ph2 ELARA trial, with 86% and 68% of patients achieving an ORR and CR, respectively. The Celltelligence team will be conducting a full thoughts-on analysis and label review in the coming days (link to PI).

About The Author

The Celltelligence Team

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Content Leads & Contributors
The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.