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Autologous, CAR-T, CD19

November 17, 2020

Thoughts on Liso-cel’s Incomplete FDA Review; PDUFA Analysis may have Possible Implications for CAR-T CMOs and Manufacturing Partnerships

Here is a brief preview of this blast: Yesterday, November 16, 2020, BMS announced (press release) that the FDA informed the company that its BLA review for liso-cel (CD19 CAR-T) in ≥3L r/r LBCL will not be completed by the PDUFA action date of November 16, 2020. Management confirmed that the FDA was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic. Below, Celltelligence provides thoughts on the missed PDUFA action date, how liso-cel's progress compares with other CAR-T PDUFA dates, and the risk associated with using a CMO (clinical manufacturing organization) for commercially manufacturing CAR-T products.

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The Celltelligence Team

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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.