Carvykti® (ciltacabtagene autoleucel)

BL 125746

Carvykti® (ciltacabtagene autoleucel)

BL 125746

U.S. License Holder:

Janssen Biotech, Inc.

Date of License:

February-28-2022

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

CARVYKTI (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2021-01484

U.S. Patent No.
9,765,342 (Chimeric Antigen Receptors Targeting B-Cell Maturation Antigen)

Patent Owner
The United States of America as Reprsented by the Seretary of Health and Human Services; 2seventy bio Inc.; bluebird bio, Inc.; Cartesian Therapeutics, Inc.; Thirsty Brook Bioscience, Inc.

Petitioner(s)
Janssen Biotech, Inc.; Janssen Pharmaceutica NV; Legend Biotech Ireland Limited; Legend Biotech USA, Inc.; Nanjing Legend Biotechnology Co., Ltd.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-9, 13, 17, 19

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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