Breyanzi® (lisocabtagene maraleucel)

BL 125714

Breyanzi® (lisocabtagene maraleucel)

BL 125714

U.S. License Holder:

Juno Therapeutics / Bristol-Myers Squibb

Date of License:

June-24-2022

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

BREYANZI (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:

Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or

Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or

Relapsed or refractory disease after 2 or more lines of systemic therapy;

Adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor;

Adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy;

Adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

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

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

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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