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lisocabtagene maraleucel

Trade name: Breyanzi

Cell therapyapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Feb 5, 2021

Juno Therapeutics, Inc. was an American biopharmaceutical company founded in 2013 through a collaboration of the Fred Hutchinson Cancer Research Center, Memorial Sloan-Kettering Cancer Center and pediatrics partner Seattle Children's Research Institute. The company was launched with an initial investment of $120 million, with a remit to develop a pipeline of cancer immunotherapy drugs. The company raised $300 million through private funding and a further $265 million through their IPO. — Wikipedia

Clinical trial activity

15 trials · 16 clinical orgs · 1 marketing orgs

Phase 1
3
Phase 2
12
Phase 3
2
Phase 4
0

Earliest trial started Jul 26, 2018 (NCT03483103)

Timeline

2010s

  1. Apr 27, 2016

    Orphan Drug Designation

  2. Jan 1, 2018

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Feb 5, 2021

    Bristol-Myers Squibb — Earliest FDA Approval

  2. Feb 5, 2021

    Bristol-Myers Squibb — NDA Secondary Org

  3. Feb 5, 2021

    Bristol-Myers Squibb — NDA Organization

  4. Jan 1, 2022

    Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 2024

    Bristol-Myers Squibb — Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedBreakthroughFeb 5, 2021

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07194980Phase 2Dec 31, 2025Merck, University of Washington
NCT07098364Phase 1/Phase 2 (Phase 2)Dec 1, 2025Simcha, University of Washington
NCT07015242Phase 2Nov 6, 2025Bristol-Myers Squibb
NCT06313996Phase 3Mar 29, 2024Bristol-Myers Squibb, Celgene
NCT06205290Phase 3Jan 16, 2024Bristol-Myers Squibb, Celgene
NCT05873712Phase 2Jul 28, 2023Ohio State University
NCT05672173Phase 2Jun 2, 2023City of Hope National Medical Center, National Cancer Institute (NCI)
NCT05621096Phase 1Jan 31, 2023Bristol-Myers Squibb, University of Nebraska
NCT05359211Phase 1Dec 28, 2022Nektar Therapeutics, University of Washington
NCT05633615Phase 2Dec 4, 2022Genentech, National Cancer Institute (NCI), SWOG Cancer Research Network
NCT05583149Phase 2Oct 31, 2022AstraZeneca, Harvard University
NCT03642626Phase 2Dec 18, 2018University of Minnesota
NCT03744676Phase 2Nov 29, 2018Celgene, Juno Therapeutics, Inc.
NCT03483103Phase 2Jul 26, 2018Celgene, Juno Therapeutics, Inc.
NCT04400591N/A—Bristol-Myers Squibb, Juno Therapeutics, Inc.
Showing 15 of 15 trials
Page 1 / 1

Organizations

Research & Development (16)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bristol-Myers SquibbFor profit5342023
CelgeneFor profit4022018
Juno Therapeutics, Inc.For profit3322018
University of WashingtonAcademic/Hospital3322022
National Cancer Institute (NCI)Government2012022
AstraZenecaFor profit1012022
City of Hope National Medical CenterAcademic/Hospital1112023
GenentechFor profit1012022
Harvard UniversityAcademic/Hospital1112022
MerckFor profit1012025
Nektar TherapeuticsFor profit1012022
Ohio State UniversityAcademic/Hospital1112023
SimchaFor profit1012025
SWOG Cancer Research NetworkAcademic/Hospital1112022
University of MinnesotaAcademic/Hospital1112018
University of NebraskaAcademic/Hospital1112023
16 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Bristol-Myers SquibbFor profitNDA2Feb 5, 2021
Bristol-Myers SquibbFor profitNDAFeb 5, 2021