Liso-cel

Developed for: B-cell chronic lymphocytic leukemia · B-cell neoplasm · follicular lymphoma · high grade B-cell lymphoma · primary mediastinal large B-cell lymphoma
Investigated by: Celgene Corporation · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Bristol-Myers Squibb · University of Nebraska

Trials 3

today NCT06313996 · Ph 3 NCT06205290 · Ph 3 NCT05621096 · Ph 1

2023202420252026202720282029203020312032

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT05621096	Mar 2023 → Jan 2025 overdue	follicular lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma	University of Nebraska	Active not recruiting	No outcome recorded
Phase 32 trials
Phase 3	NCT06313996	Mar 2024 → Oct 2031	B-cell neoplasm	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company	Withdrawn	No outcome recorded
Phase 3	NCT06205290	Jan 2024 → Oct 2031	B-cell chronic lymphocytic leukemia	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company	Withdrawn	No outcome recorded Stop: Business

Press releases naming this drug 28 releases

Date	Issuer	Release
2025-08-04	Bristol-Myers Squibb	Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) Accepted for Priority Review by U.S. Food and Drug Administration (FDA) in Fifth Cancer Type for Relapsed or Refractory Marginal Zone Lymphoma (MZL) bms.com ↗
2025-06-16	Bristol-Myers Squibb	Bristol Myers Squibb Presents First Data from the Marginal Zone Lymphoma Cohort of the Transcend FL Trial Demonstrating Deep and Durable Responses with Breyanzi (lisocabtagene maraleucel) bms.com ↗
2025-02-10	Bristol-Myers Squibb	Bristol Myers Squibb Announces Positive Topline Results for Breyanzi® (lisocabtagene maraleucel) in Adult Patients with Relapsed or Refractory Marginal Zone Lymphoma bms.com ↗
2024-01-30	Bristol-Myers Squibb	Regulatory Applications Accepted in the U.S. and Japan for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) in Relapsed or Refractory Follicular Lymphoma (FL) and Relapsed or Refractory Mantle Cell Lymphoma (MCL) bms.com ↗
2023-11-09	Bristol-Myers Squibb	U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel)for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) bms.com ↗
2023-06-17	Bristol-Myers Squibb	Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) Delivers Deep and Durable Responses in Relapsed or Refractory Follicular Lymphoma and Mantle Cell Lymphoma in TRANSCEND Clinical Trials Presented at ICML 2023 bms.com ↗
2023-05-30	Bristol-Myers Squibb	Bristol Myers Squibb to Present Late-Breaking Data for Breyanzi (lisocabtagene maraleucel) in Relapsed or Refractory Follicular Lymphoma and Mantle Cell Lymphoma at 2023 International Conference on Malignant Lymphoma bms.com ↗
2023-05-25	Bristol-Myers Squibb	Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) is First and Only CAR T to Deliver Deep and Durable Efficacy in Pivotal Multicenter Trial in Relapsed or Refractory Chronic Lymphocytic Leukemia, Based on Data Presented at ASCO 2023 bms.com ↗
2023-05-03	Bristol-Myers Squibb	Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy bms.com ↗
2023-05-01	Bristol-Myers Squibb	Bristol Myers Squibb’s TRANSCEND FL and TRANSCEND NHL 001 Studies of Breyanzi (lisocabtagene maraleucel)in Relapsed or Refractory Follicular Lymphoma and Mantle Cell Lymphoma Meet Primary Endpoint of Overall Response Rate bms.com ↗
2023-03-31	Bristol-Myers Squibb	Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy bms.com ↗
2023-01-26	Bristol-Myers Squibb	Bristol Myers Squibb Announces TRANSCEND CLL 004 Trial of Breyanzi® (lisocabtagene maraleucel) Met Primary Endpoint of Complete Response Rate in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia bms.com ↗
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 ↗
2022-02-17	Bristol-Myers Squibb	U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Supplemental Biologics License Application for Breyanzi (lisocabtagene maraleucel) as a Second-Line Therapy for Relapsed or Refractory Large B-cell Lymphoma bms.com ↗
2022-01-28	Bristol-Myers Squibb	Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory DLBCL, PMBCL and FL3B bms.com ↗
2021-12-11	Bristol-Myers Squibb	Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) Significantly Improves Outcomes, Showing Superiority Over 20-Year Standard of Care in Second-Line Relapsed or Refractory Large B-cell Lymphoma Based on TRANSFORM Study Results bms.com ↗
2021-06-10	Bristol-Myers Squibb	Bristol Myers Squibb Announces Positive Topline Results from Phase 3 TRANSFORM Trial Evaluating Breyanzi (lisocabtagene maraleucel) Versus Chemotherapy Followed by Stem Cell Transplant in Second-line Relapsed or Refractory Large B-cell Lymphoma bms.com ↗
2021-02-05	Bristol-Myers Squibb	U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), a New CAR T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma bms.com ↗
2021-01-01	Bristol-Myers Squibb	Bristol Myers Squibb Statement on Status of Liso-cel Application and Contingent Value Rights bms.com ↗
2020-12-07	Bristol-Myers Squibb	Bristol Myers Squibb Presents Data Evaluating Potential of Liso-cel Across Leukemia and Lymphomas at ASH 2020 bms.com ↗
2020-11-16	Bristol-Myers Squibb	Bristol Myers Squibb Provides Regulatory Update on Lisocabtagene Maraleucel (liso-cel) bms.com ↗
2020-07-17	Bristol-Myers Squibb	European Medicines Agency Validates Bristol Myers Squibb’s Application for CAR T Cell Therapy Lisocabtagene Maraleucel (liso-cel) bms.com ↗
2020-05-06	Bristol-Myers Squibb	Bristol Myers Squibb Provides Update on Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) bms.com ↗
2020-02-13	Bristol-Myers Squibb	U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma bms.com ↗
2019-12-18	Bristol-Myers Squibb	Bristol-Myers Squibb Announces Submission of Biologics License Application for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel) to FDA bms.com ↗
2019-12-08	Bristol-Myers Squibb	Bristol-Myers Squibb Announces Studies Evaluating liso-cel in Multiple Additional Patient Populations, Site of Care and Disease Areas Presented at American Society of Hematology (ASH) Annual Meeting bms.com ↗
2019-12-07	Bristol-Myers Squibb	Bristol-Myers Squibb Announces Liso-Cel Met Primary and Secondary Endpoints in TRANSCEND NHL 001 Study bms.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

Field	Value	Cited text
Known as	Liso-cel	ClinicalTrials.gov intervention name — accepted as the source's own label NCT06313996 ↗ 2 NCT06205290 ↗ NCT05621096 ↗
Known as	lisocabtagene maraleucel	“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 ↗
Modality	Cell therapy	“chimeric antigen receptor (CAR) T-cell treatment” NCT05621096 ↗