Yescarta® (axicabtagene ciloleucel)

BL 125643

Yescarta® (axicabtagene ciloleucel)

BL 125643

U.S. License Holder:

Kite Pharma, Inc.

Date of License:

October-18-2017

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy;

Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma;

Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2015-01719

U.S. Patent No.
7,446,190 (Nucleic Acids Encoding Chimeric T Cell Receptors)

Patent Owner
Sloan Kettering Institute for Cancer Research; Juno Therapeutics, Inc.

Petitioner(s)
Kite Pharma, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-13

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
17-1647

IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable); Federal Circuit Appeal: Rule 36 Affirmance

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:16-cv-01243 (D. Del.)

U.S. Patent Nos.
7,446,190 (Nucleic Acids Encoding Chimeric T Cell Receptors)

Plaintiffs
Juno Therapeutics, Inc.; Memorial Sloan-Kertering Cancer Center; Sloan Kettering Institute for Cancer Research

Defendants
Kite Pharma, Inc.

Status
Dismissed

BPCIA
N

1:19-cv-01732 (D. Del.)

U.S. Patent Nos.
7,741,465 (Chimeric Receptor Genes and Cells Transformed Therewith)

Plaintiffs
Cabaret Biotech Ltd.

Defendants
Kite Pharma, Inc.; Gilead Sciences, inc.

Status
Stipulated Dismissal

BPCIA
N

2:17-cv-06496 (C.D. Cal.)

U.S. Patent Nos.
7,446,190 (Nucleic Acids Encoding Chimeric T Cell Receptors)

Plaintiffs
Juno Therapeutics, Inc.; Memorial Sloan-Kertering Cancer Center; Sloan Kettering Institute for Cancer Research

Defendants
Kite Pharma, Inc.

Status
Volutarily Dismissed

BPCIA
N

2:17-cv-07639 (C.D. Cal.)

U.S. Patent Nos.
7,446,190 (Nucleic Acids Encoding Chimeric T Cell Receptors)

Plaintiffs
Juno Therapeutics, Inc.; Memorial Sloan-Kertering Cancer Center; Sloan Kettering Institute for Cancer Research

Defendants
Kite Pharma, Inc.

Federal Circuit Appeal(s)
20-1758

Supreme Court Appeal(s)
21-1566

Status
Jury Verdict (Patents Valid and Infringed) with Award of Damages and Ongoing Royalty; Federal Circuit Appeal Reversed, Petition for Panel and En Banc Rehearing Denied; Petition for Writ of Certiorari Denied, Request for Rehearing Denied

BPCIA
N

3:19-cv-00670 (E.D. Va.) (transferred from 1:19-cv-01193 (E.D. Va.))

U.S. Patent Nos.
7,741,465 (Chimeric Receptor Genes and Cells Transformed Therewith)

Plaintiffs
Kite Pharma, Inc.; Gilead Sciences, inc.

Defendants
Cabaret Biotech Ltd.

Status
Voluntarily Dismissed

BPCIA
N

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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