Home PurpleBook 125746 Carvykti Purple Book BLA 125746
BLA number 125746
Proprietary names Carvykti
Proper names ciltacabtagene autoleucel
Applicant Janssen Biotech, Inc.
Center CBER
First observed release 2022-02-01
Latest observed release 2026-06-01
Newest archive release 2026-06-01
FDA patent list No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage Present in newest release Latest Known Product Presentations# Product, Proprietary name, Proper name table Product Proprietary name Proper name License type Strength Dosage form Route Presentation Marketing Licensure Approval Patent list provided 001 Carvykti ciltacabtagene autoleucel 351(a) 0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion For Injection Intravenous Bag Rx Licensed 2022-02-28
Published Patent List# No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events# Release, Event, Product table Release Event Product Name License type Status Applicant 2024-05-01 U 001 Carvykti 351(a) Rx Janssen Biotech, Inc. 2023-06-01 U 001 Carvykti 351(a) Rx Janssen Biotech, Inc. 2023-02-01 U 001 Carvykti 351(a) Rx Janssen Biotech, Inc. 2022-03-01 U 001 Carvykti 351(a) Rx Janssen Biotech, Inc. 2022-02-01 N 001 Carvykti 351(a) Rx Janssen Biotech, Inc.
Observed Product State History# Release, Product, Name table Release Product Name License type Marketing Licensure Approval 2022-02-01 001 Carvykti 351(a) Rx Licensed 2022-02-28
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