Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Breyanzi | — | 2022-04-04 | europa.eu ↗ |
Trials 21 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07052305 Background | Mar 2026 → Nov 2027 expected | large B-cell lymphoma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT05359211 Background | Dec 2022 → Sep 2025 overdue | primary mediastinal large B-cell lymphoma | Fred Hutchinson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05075603 Background | Aug 2021 → Dec 2024 | high grade B-cell lymphoma | NeoImmuneTech | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04855253 Background | Jun 2021 → Sep 2026 | high grade B-cell lymphoma | Masonic Cancer Center, University of Minnesota | Suspended | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05934448 Background | Nov 2023 → Jun 2027 expected | T-cell/histiocyte rich large B cell lymphoma, primary mediastinal large B-cell lymphoma | Jennifer Crombie, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05633615 Background | Jun 2023 → Jun 2030 expected | primary mediastinal large B-cell lymphoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07188558 Comparator | Jan 2026 → Dec 2029 expected | diffuse large B-cell lymphoma, large B-cell lymphoma | Lyell Immunopharma, Inc. | Recruiting | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-04-05 | Bristol-Myers Squibb | Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Certain Forms of Relapsed or Refractory Large B-cell Lymphoma bms.com ↗ |
| 2022-03-25 | Bristol-Myers Squibb | Japan's Ministry of Health, Labour and Welfare Accepts Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) as a Second-Line Therapy for Relapsed or Refractory Large B-cell Lymphoma bms.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lisocabtagene maraleucel | “The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in...” NCT07015242 ↗18“The Food and Drug Administration (FDA) has recently approved lisocabtagene maraleucel (liso-cel) for the management of people with relapsed and refractory B-cell lymphoma.” NCT05621096 ↗ “Standard of care: Will be given on day 0 and will be either axicabtagene ciloleucel or lisocabtagene maraleucel .” NCT07052305 ↗ “The CAR T-cell therapies to be used in this study are axicabtagene-ciloleucel and lisocabtagene maraleucel.” NCT05934448 ↗ “Lisocabtagene maraleucel is a CAR-T cell therapy made from an individual's own immune (T) cells.” NCT07711483 ↗ “JCAR017 (lisocabtagene maraleucel) single-dose schedule” NCT02631044 ↗ |
| Known as | BMS-986387 | “The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in...” NCT07015242 ↗ |
| Known as | Breyanzi | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03642626 ↗ |
| Known as | JCAR017 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03484702 ↗ |
| Known as | liso-cel | “The goal of this clinical trial is to assess the clinical efficacy of bridging therapy with glofitamab/gemcitabine/oxaliplatin (Glofit-GemOx) followed by lisocabtagene...” NCT07711483 ↗6“The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in...” NCT07015242 ↗ “zanubrutinib and lisocabtagene maraleucel (liso-cel) work together” NCT05873712 ↗ “liso-cel” NCT03744676 ↗ |
| Known as | Lisocabtagen maraleucel | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297236 ↗ |
| Action | Deplete | “cytolytic activity” PMID 35610089 ↗ May 2022 |
| Modality | Cell therapy | “Gene modified autologous T cells” NCT03310619 ↗ |
| Route | Intravenous | “one dose of JCAR017 administered by intravenous (IV) injection” NCT03331198 ↗ |
| Target | CD19 | “an autologous, CD19-directed chimeric antigen receptor (CAR) T-cell product” PMID 35839786 ↗ Jul 2022 |