Bristol Myers Squibb Receives Approval from the European Commission to Expand Use of CAR T Cell Therapy Breyanzi for Relapsed or Refractory Follicular Lymphoma
Bristol Myers Squibb (NYSE: BMY) has received European Commission approval for Breyanzi to treat adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
The approval is based on the Phase 2 TRANSCEND FL study results, showing:
- 97.1% overall response rate
- 94.2% complete response rate
- 75.7% of patients maintained response at 18 months
- Median time to first response of 0.95 months
Safety profile remained consistent with previous trials, with 58% of patients experiencing cytokine release syndrome (only 0.8% Grade 3) and 16% experiencing neurologic toxicities (3% Grade 3). The approval extends to all EU member states and EEA countries.
Bristol Myers Squibb (NYSE: BMY) ha ricevuto l'approvazione della Commissione Europea per Breyanzi per trattare pazienti adulti con linfoma follicolare (FL) recidivante o refrattario dopo due o più linee di terapia sistemica.
L'approvazione si basa sui risultati dello studio di Fase 2 TRANSCEND FL, che mostrano:
- tasso di risposta complessiva del 97,1%
- tasso di risposta completa del 94,2%
- il 75,7% dei pazienti ha mantenuto la risposta a 18 mesi
- tempo mediano per la prima risposta di 0,95 mesi
Il profilo di sicurezza è rimasto coerente con studi precedenti, con il 58% dei pazienti che ha sperimentato sindrome da rilascio di citochine (solo lo 0,8% di Grado 3) e il 16% che ha sperimentato tossicità neurologiche (3% di Grado 3). L'approvazione si estende a tutti gli stati membri dell'UE e ai paesi SEE.
Bristol Myers Squibb (NYSE: BMY) ha recibido la aprobación de la Comisión Europea para Breyanzi para tratar a pacientes adultos con linfoma folicular (FL) en recaída o refractario después de dos o más líneas de terapia sistémica.
La aprobación se basa en los resultados del estudio de Fase 2 TRANSCEND FL, que muestran:
- tasa de respuesta global del 97,1%
- tasa de respuesta completa del 94,2%
- el 75,7% de los pacientes mantuvo la respuesta a los 18 meses
- tiempo mediano hasta la primera respuesta de 0,95 meses
El perfil de seguridad se mantuvo consistente con ensayos previos, con el 58% de los pacientes experimentando síndrome de liberación de citoquinas (solo el 0,8% Grado 3) y el 16% experimentando toxicidades neurológicas (3% Grado 3). La aprobación se extiende a todos los estados miembros de la UE y a los países del EEE.
브리스톨 마이어스 스퀴브 (NYSE: BMY)는 브레이얀지에 대해 두 번 이상의 전신 요법 후 재발 또는 불응성 여포 림프종(FL) 치료를 위한 유럽연합 집행위원회의 승인을 받았습니다.
이번 승인은 2상 TRANSCEND FL 연구 결과에 기반하고 있으며, 다음과 같은 결과를 보여줍니다:
- 97.1%의 전체 반응률
- 94.2%의 완전 반응률
- 75.7%의 환자가 18개월 동안 반응을 유지
- 첫 번째 반응까지의 중앙 시간은 0.95개월
안전성 프로필은 이전 시험과 일치하며, 58%의 환자가 사이토카인 방출 증후군을 경험하였고(3등급은 0.8%에 불과) 16%가 신경 독성을 경험하였습니다(3등급은 3%). 이번 승인은 모든 EU 회원국 및 EEA 국가로 확대됩니다.
Bristol Myers Squibb (NYSE: BMY) a reçu l'approbation de la Commission européenne pour Breyanzi afin de traiter les patients adultes atteints de lymphome folliculaire (FL) en rechute ou réfractaire après deux lignes ou plus de thérapie systémique.
L'approbation est basée sur les résultats de l'étude de Phase 2 TRANSCEND FL, montrant :
- un taux de réponse global de 97,1%
- un taux de réponse complète de 94,2%
- 75,7% des patients ont maintenu leur réponse à 18 mois
- un temps médian jusqu'à la première réponse de 0,95 mois
Le profil de sécurité est resté cohérent avec les essais précédents, avec 58% des patients présentant un syndrome de libération de cytokines (seulement 0,8% de Grade 3) et 16% présentant des toxicités neurologiques (3% de Grade 3). L'approbation s'étend à tous les États membres de l'UE et aux pays de l'EEE.
Bristol Myers Squibb (NYSE: BMY) hat die Genehmigung der Europäischen Kommission für Breyanzi zur Behandlung von erwachsenen Patienten mit rezidiviertem oder refraktärem follikulärem Lymphom (FL) nach zwei oder mehr Linien systemischer Therapie erhalten.
Die Genehmigung basiert auf den Ergebnissen der Phase-2-Studie TRANSCEND FL, die Folgendes zeigt:
- 97,1% Gesamtansprechrate
- 94,2% vollständige Ansprechrate
- 75,7% der Patienten hielten die Antwort nach 18 Monaten aufrecht
- Mediane Zeit bis zur ersten Antwort von 0,95 Monaten
Das Sicherheitsprofil blieb konsistent mit früheren Studien, wobei 58% der Patienten ein Zytokinfreisetzungssyndrom erlebten (nur 0,8% Grad 3) und 16% neurologische Toxizitäten erlitten (3% Grad 3). Die Genehmigung erstreckt sich auf alle EU-Mitgliedstaaten und EWR-Länder.
- High efficacy with 97.1% overall response rate and 94.2% complete response rate
- Strong durability with 75.7% of patients maintaining response at 18 months
- Rapid response time with median of 0.95 months
- European market expansion through EC approval
- Safety concerns with 58% of patients experiencing cytokine release syndrome
- 16% of patients experienced neurologic toxicities
Insights
The European Commission approval of Breyanzi for relapsed/refractory follicular lymphoma represents a significant advancement in treatment options. The 97.1% overall response rate and
Follicular lymphoma presents unique challenges - while initially responsive to treatment, patients invariably relapse, with progressively shorter remissions after each subsequent therapy. This pattern creates a critical need for treatments that can break this cycle. The rapid median time to response (0.95 months) coupled with durable outcomes suggests Breyanzi could fulfill this need.
The safety profile shows expected CAR T toxicities but remains manageable. The low rate of Grade 3 CRS (
This approval establishes Breyanzi as an important option in the treatment algorithm for follicular lymphoma patients who have exhausted conventional therapies. The high complete response rate is particularly meaningful in this incurable disease, where quality and duration of remission directly impact patient quality of life.
This European Commission approval significantly strengthens BMY's cell therapy franchise by expanding Breyanzi's addressable market to include follicular lymphoma patients in the third-line setting. The approval covers all EU member states plus Iceland, Norway, and Liechtenstein, representing a substantial commercial opportunity.
The exceptional efficacy data from TRANSCEND FL positions Breyanzi competitively in the European market. With follicular lymphoma representing
This approval builds on Breyanzi's existing EU indications in various types of large B-cell lymphomas, creating economies of scale for BMY's cell therapy infrastructure. The company can leverage established treatment centers, reimbursement pathways, and healthcare provider relationships across multiple indications.
The high complete response rate and durability of response differentiate Breyanzi in a therapeutic area where patients cycle through multiple treatments over their disease course. This efficacy profile, coupled with the manageable safety data, should support reimbursement negotiations with European payers.
While CAR T therapies face implementation challenges including specialized administration requirements and manufacturing logistics, BMY continues expanding Breyanzi across multiple indications and geographies. This approval represents another execution milestone in the company's cell therapy strategy, addressing an important area of unmet need while leveraging their established CAR T platform.
In the TRANSCEND FL trial,
Breyanzi demonstrated sustained clinical benefit, with
“This additional approval for Breyanzi in FL represents a critical step forward in our mission to deliver on the transformational promise of cell therapy for more patients across Europe,” said Emma Charles, senior vice president,
The decision is based on results from the global, Phase 2 TRANSCEND FL study, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL. Among patients treated in the third-line plus setting, Breyanzi demonstrated a high overall response rate of
Safety results were consistent with the well-established safety profile of Breyanzi observed across clinical trials and approved indications, with no new safety signals observed in FL. In all patients treated in the TRANSCEND FL study (second-line plus), any grade cytokine release syndrome (CRS) occurred in
This expanded approval is applicable to all European Union (EU) member states as well as the European Economic Area (EEA) countries
*The trial followed the Lugano criteria (2014) which permits assessment of CR in the bone marrow by PET-CT. Using these criteria defined in the trial, the CR rate in the Summary of Product Characteristics (and publication ref: Morschhauser F,e. al. Nat Med. 2024 Aug;30(8):2199-2207) was established (
**Centralized Marketing Authorization does not include approval in the
About TRANSCEND FL
TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in adult patients with relapsed or refractory indolent B-cell NHL, including FL. The primary outcome measure is overall response rate, including best overall response of complete response or partial response as determined by an Independent Review Committee. Secondary outcome measures include complete response rate, duration of response, progression-free survival and safety.
About Follicular Lymphoma
Follicular lymphoma (FL) is the second most common form of NHL, accounting for 20
About Breyanzi
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment.
Breyanzi is approved in the
Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in other types of lymphoma. For more information, visit clinicaltrials.gov.
The European Summary of Product Characteristics for Breyanzi will be available from the European Commission and EMA websites at www.ema.europa.eu.
BREYANZI 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 two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.
- 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. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- 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.
BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES
- Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
- Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
- T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.
- BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.
Cytokine Release Syndrome
Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in
Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.
Neurologic Toxicities
Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred.
In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in
The most common neurologic toxicities (≥
CRS and Neurologic Toxicities Monitoring
Monitor patients daily for at least 7 days following BREYANZI infusion at a REMS-certified healthcare facility for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.
BREYANZI REMS
Because of the risk of CRS and neurologic toxicities, BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS. The required components of the BREYANZI REMS are:
- Healthcare facilities that dispense and administer BREYANZI must be enrolled and comply with the REMS requirements.
- Certified healthcare facilities must have on-site, immediate access to tocilizumab.
- Ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after BREYANZI infusion, if needed for treatment of CRS.
Further information is available at www.BreyanziREMS.com, or contact Bristol Myers Squibb at 1-866-340-7332.
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).
Serious Infections
Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in
Febrile neutropenia developed after BREYANZI infusion in
Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections.
Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy.
Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.
Prolonged Cytopenias
Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in
Hypogammaglobulinemia
B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in
Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.
Secondary Malignancies
Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.
Effects on Ability to Drive and Use Machines
Due to the potential for neurologic events, including altered mental status or seizures, patients receiving BREYANZI are at risk for developing altered or decreased consciousness or impaired coordination in the 8 weeks following BREYANZI administration. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks.
Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)
Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (
Adverse Reactions
The most common adverse reaction(s) (incidence ≥
- LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
- CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.
- FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.
- MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy
A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease.
Bristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy’s transformational potential.
The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities— are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the CHMP opinion is not binding on the EC, that Breyanzi (lisocabtagene maraleucel) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether Breyanzi for such indication will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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FAQ
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