Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma
Regeneron Pharmaceuticals (NASDAQ: REGN) announced the FDA's acceptance of their resubmitted Biologics License Application (BLA) for odronextamab in treating relapsed/refractory follicular lymphoma. The FDA decision is expected by July 30, 2025.
The resubmission follows meeting the FDA-mandated enrollment target for the Phase 3 OLYMPIA-1 confirmatory trial. Phase 1 and 2 trials showed promising results with an 80% overall response rate (n=103) and 74% complete response rate (n=95). However, serious adverse events occurred in 67% of patients, including cytokine release syndrome, COVID-19, and pneumonia.
The drug is already approved as Ordspono™ in the European Union for treating relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Regeneron Pharmaceuticals (NASDAQ: REGN) ha annunciato l'accettazione da parte della FDA della loro domanda di licenza biologica (BLA) per odronextamab nel trattamento del linfoma follicolare recidivante/refrattario. La decisione della FDA è attesa entro il 30 luglio 2025.
La ripresentazione segue il raggiungimento dell'obiettivo di arruolamento imposto dalla FDA per la fase 3 dello studio OLYMPIA-1. Gli studi di fase 1 e 2 hanno mostrato risultati promettenti con un 80% di tasso di risposta complessiva (n=103) e un 74% di tasso di risposta completa (n=95). Tuttavia, eventi avversi gravi si sono verificati nel 67% dei pazienti, inclusi sindrome da rilascio di citochine, COVID-19 e polmonite.
Il farmaco è già approvato come Ordspono™ nell'Unione Europea per il trattamento del linfoma follicolare recidivante/refrattario o del linfoma diffuso a grandi cellule B dopo due o più linee di terapia sistemica.
Regeneron Pharmaceuticals (NASDAQ: REGN) anunció la aceptación por parte de la FDA de su solicitud de licencia biológica (BLA) para odronextamab en el tratamiento del linfoma folicular en recaída/refractario. Se espera que la decisión de la FDA se tome antes del 30 de julio de 2025.
La re-presentación sigue el cumplimiento del objetivo de inscripción requerido por la FDA para el ensayo confirmatorio de fase 3 OLYMPIA-1. Los ensayos de fase 1 y 2 mostraron resultados prometedores con un 80% de tasa de respuesta global (n=103) y un 74% de tasa de respuesta completa (n=95). Sin embargo, ocurrieron eventos adversos graves en el 67% de los pacientes, incluidos el síndrome de liberación de citoquinas, COVID-19 y neumonía.
El medicamento ya está aprobado como Ordspono™ en la Unión Europea para el tratamiento del linfoma folicular en recaída/refractario o linfoma difuso de células B grandes después de dos o más líneas de terapia sistémica.
레제너론 제약 (NASDAQ: REGN)은 오드로넥스타맙의 재발/난치성 여포 림프종 치료를 위한 생물학적 제품 허가 신청(BLA)이 FDA에 의해 수락되었음을 발표했습니다. FDA의 결정은 2025년 7월 30일까지 예상됩니다.
재신청은 3상 OLYMPIA-1 확인 시험에 대한 FDA가 요구한 등록 목표를 충족한 후 이루어졌습니다. 1상 및 2상 시험에서 80%의 전체 반응률 (n=103)과 74%의 완전 반응률 (n=95)로 유망한 결과를 보였습니다. 그러나 67%의 환자에서 사이토카인 방출 증후군, COVID-19 및 폐렴을 포함한 심각한 부작용이 발생했습니다.
이 약물은 이미 두 번 이상의 전신 치료 후 재발/난치성 여포 림프종 또는 미만성 대세포 B 림프종 치료를 위해 유럽 연합에서 Ordspono™로 승인되었습니다.
Regeneron Pharmaceuticals (NASDAQ: REGN) a annoncé l'acceptation par la FDA de leur demande de licence biologique (BLA) pour odronextamab dans le traitement du lymphome folliculaire en rechute/résistant. La décision de la FDA est attendue d'ici le 30 juillet 2025.
La nouvelle soumission fait suite à l'atteinte de l'objectif d'inscription imposé par la FDA pour l'essai de confirmation de phase 3 OLYMPIA-1. Les essais de phase 1 et 2 ont montré des résultats prometteurs avec un taux de réponse global de 80% (n=103) et un taux de réponse complète de 74% (n=95). Cependant, des événements indésirables graves sont survenus chez 67% des patients, y compris le syndrome de libération de cytokines, le COVID-19 et la pneumonie.
Le médicament est déjà approuvé en tant qu'Ordspono™ dans l'Union Européenne pour le traitement du lymphome folliculaire en rechute/résistant ou du lymphome diffus à grandes cellules B après deux ou plusieurs lignes de thérapie systémique.
Regeneron Pharmaceuticals (NASDAQ: REGN) gab die Annahme ihres erneut eingereichten Antrags auf eine Biologika-Lizenz (BLA) für odronextamab zur Behandlung von rezidivierenden/refraktären follikulären Lymphomen durch die FDA bekannt. Die Entscheidung der FDA wird bis zum 30. Juli 2025 erwartet.
Die Wiederanmeldung folgt der Erfüllung des von der FDA geforderten Einschreibeziels für die Phase-3-Studie OLYMPIA-1. Die Phase-1- und 2-Studien zeigten vielversprechende Ergebnisse mit einer 80%igen Gesamtansprechrate (n=103) und einer 74%igen vollständigen Ansprechrate (n=95). Allerdings traten bei 67% der Patienten schwere unerwünschte Ereignisse auf, darunter das Zytokinfreisetzungssyndrom, COVID-19 und Pneumonie.
Das Medikament ist bereits in der Europäischen Union als Ordspono™ zur Behandlung von rezidivierenden/refraktären follikulären Lymphomen oder diffus großzelligen B-Lymphomen nach zwei oder mehr Linien systemischer Therapie zugelassen.
- FDA accepted BLA resubmission for odronextamab
- High efficacy: 80% overall response rate in trials
- 74% complete response rate in clinical trials
- Already approved in EU market
- High rate (67%) of serious adverse events
- Final FDA approval still pending until July 2025
Insights
The FDA's acceptance of Regeneron's resubmitted BLA for odronextamab represents a critical advancement for patients with relapsed/refractory follicular lymphoma who have exhausted standard treatments. The 74% complete response rate in the pivotal trials is exceptionally high for this patient population, where complete responses typically become increasingly difficult to achieve after multiple therapy failures.
Follicular lymphoma affects approximately 15,000 new patients annually in the US, with roughly 20% becoming refractory after second-line treatment. This creates a significant market opportunity for effective therapies in later lines. Odronextamab, a CD20xCD3 bispecific antibody, works by redirecting T-cells to eliminate malignant B-cells - a mechanism distinct from conventional antibodies or CAR-T approaches.
The safety profile, while showing serious adverse events in
For Regeneron, this represents strategic diversification beyond their traditional focus on immunology and ophthalmology into hematologic malignancies. If approved by the July 30 target date, odronextamab could become an important growth driver, potentially generating
The FDA's acceptance of Regeneron's odronextamab BLA marks a significant advancement in the company's oncology commercialization strategy. The follicular lymphoma market represents a
This development strengthens Regeneron's diversification efforts beyond its core revenue drivers Eylea and Dupixent, which currently account for over
Odronextamab will face competition from established therapies like Roche's Polivy and emerging bispecifics, but its 74% complete response rate positions it favorably. Based on European pricing benchmarks, annual treatment cost could range from
Regeneron has been building its hematology-oncology commercial infrastructure over the past two years, with sales force expansion and specialized market access teams. This infrastructure investment should support efficient commercialization if approved.
The regulatory progress reduces near-term pipeline risk and should improve investor confidence in Regeneron's ability to offset potential Eylea biosimilar competition in coming years. From a valuation perspective, this program could add
FDA decision expected by July 30, 2025
TARRYTOWN, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The target action date for the FDA decision is July 30, 2025.
Acceptance of the BLA resubmission follows the achievement of an FDA-mandated enrollment target for the Phase 3 confirmatory trial in R/R FL (OLYMPIA-1). This was the sole approvability issue identified by the FDA in the complete response letter associated with the previous submission. The BLA resubmission is supported by data from the Phase 1 and pivotal Phase 2 trials (ELM-1 and ELM-2), which demonstrated an overall response rate of
Odronextamab is approved as Ordspono™ in the European Union for the treatment of R/R FL or diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy although its safety and efficacy have not been fully evaluated by any other regulatory authority. For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu.
About FL
FL is one of the most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). While FL is a slow-growing subtype, it is an incurable disease, and most patients will relapse after initial treatment. It is estimated that approximately 122,000 FL cases are diagnosed globally every year with more than 13,600 FL cases anticipated in the U.S. in 2025.
About the Odronextamab Clinical Development Program
Odronextamab is a CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.
ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to investigate the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy.
ELM-2 is an ongoing, open-label, multicenter Phase 2 trial investigating odronextamab across five independent disease-specific cohorts, including DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-NHL. The primary endpoint is objective response rate according to the Lugano Classification as assessed by independent review committee, and secondary endpoints include complete response, progression-free survival, overall survival and duration of response. The pivotal results in FL were published in the Annals of Oncology.
Odronextamab is being investigated in a broad clinical development program exploring its use as a monotherapy as well as in combination regimens in several types of B-NHLs in earlier lines of therapy. In FL, odronextamab is being evaluated as a monotherapy against rituximab plus standard-of-care chemotherapies in a Phase 3 confirmatory trial (OLYMPIA-1) and in combination with chemotherapy against rituximab plus standard-of-care chemotherapies in a separate Phase 3 trial (OLYMPIA-2). For more information on Regeneron’s clinical trials in blood cancer, visit the clinical trials website or contact via clinicaltrials@regeneron.com or +1 844-734-6643.
About Regeneron in Hematology
At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite® technologies to develop medicines for patients with diverse blood cancers and rare blood disorders.
Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments.
Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling.
About Regeneron's VelocImmune® Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation odronextamab; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as odronextamab for the treatment of relapsed/refractory (“R/R”) follicular lymphoma (including in the United States based on the Biologics License Application (“BLA”) resubmission discussed in this press release) or the other clinical development programs investigating odronextamab as referenced in this press release; whether the achievement a prespecified target for enrollment in the Phase 3 confirmatory trial of odronextamab discussed in this press release will be sufficient for purposes of potential approval of the resubmitted BLA for odronextamab in R/R follicular lymphoma by the U.S. Food and Drug Administration; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as odronextamab); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as odronextamab) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
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| Contacts: | |
| Media Relations Tammy Allen Tel: +1 914-306-2698 tammy.allen@regeneron.com | Investor Relations Mark Hudson Tel: +1 914-847-3482 mark.hudson@regeneron.com |
FAQ
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