BeiGene’s BGB-16673 Receives U.S. FDA Fast Track Designation for CLL/SLL
BeiGene's BGB-16673, an oral BTK-targeting chimeric degradation activation compound (CDAC), has received Fast Track Designation from the U.S. FDA for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have been previously treated with at least two prior lines of therapy. This designation aims to expedite the development and review of drugs for serious conditions with unmet medical needs.
The decision was supported by promising safety and efficacy data from a Phase 1/2 study in heavily pretreated patients. BGB-16673 is the most advanced BTK degrader in clinical trials and is expected to complement BeiGene's BRUKINSA (zanubrutinib). Over 300 patients across 15 countries have been treated with BGB-16673 in its global clinical development program.
Il BGB-16673 di BeiGene, un composto di attivazione della degradazione chimerica mirato al BTK (CDAC), ha ricevuto la Designazione Fast Track dalla FDA americana per pazienti adulti con leucemia linfatica cronica recidivante o refrattaria o linfoma linfocitico piccolo (CLL/SLL) che sono stati precedentemente trattati con almeno due linee di terapia. Questa designazione mira a velocizzare lo sviluppo e la revisione di farmaci per condizioni gravi con esigenze mediche non soddisfatte.
La decisione è stata supportata da promettenti dati di sicurezza ed efficacia provenienti da uno studio di Fase 1/2 su pazienti fortemente pretrattati. Il BGB-16673 è il degradatore di BTK più avanzato negli studi clinici e si prevede che completi il BRUKINSA (zanubrutinib) di BeiGene. Oltre 300 pazienti in 15 paesi sono stati trattati con BGB-16673 nel programma di sviluppo clinico globale.
El BGB-16673 de BeiGene, un compuesto de activación de degradación quimérica dirigido al BTK (CDAC), ha recibido la Designación Fast Track de la FDA de EE. UU. para pacientes adultos con leucemia linfocítica crónica en recaída o refractaria o linfoma linfocítico pequeño (CLL/SLL) que han sido tratados previamente con al menos dos líneas de terapia. Esta designación tiene como objetivo acelerar el desarrollo y la revisión de medicamentos para condiciones graves con necesidades médicas insatisfechas.
La decisión fue respaldada por prometedores datos de seguridad y eficacia de un estudio de Fase 1/2 en pacientes con fuerte pretratamiento. El BGB-16673 es el degradador de BTK más avanzado en ensayos clínicos y se espera que complemente el BRUKINSA (zanubrutinib) de BeiGene. Más de 300 pacientes en 15 países han sido tratados con BGB-16673 en su programa de desarrollo clínico global.
BeiGene의 BGB-16673, BTK 표적 키메라 분해 활성 화합물 (CDAC)은 미국 FDA로부터 우선 심사 지위를 받았습니다. 이 약물은 이전에 최소 두 가지 치료 방법으로 치료를 받은 성인 재발 또는 불응성 만성 림프구 백혈병 또는 소림프구 림프종 (CLL/SLL) 환자를 위해 개발되었습니다. 이 지위는 충족되지 않은 의학적 필요가 있는 심각한 질환에 대한 약물 개발 및 검토를 신속하게 진행하려는 목표를 가지고 있습니다.
이 결정은 많은 치료를 받은 환자에서의 1/2상 연구의 안전성 및 유효성 데이터에 의해 뒷받침되었습니다. BGB-16673은 현재 임상 시험에서 가장 발전된 BTK 분해제이며, BeiGene의 BRUKINSA (자누브루틴립)에 보완될 것으로 예상됩니다. 전 세계적으로 15개국에서 300명 이상의 환자가 BGB-16673으로 치료받았습니다.
Le BGB-16673 de BeiGene, un composé d'activation de dégradation chimérique ciblant le BTK (CDAC), a reçu la désignation Fast Track de la FDA américaine pour les patients adultes souffrant de leucémie lymphoïde chronique récurrente ou réfractaire ou lymphome lymphocytaire petit (CLL/SLL) qui ont déjà été traités avec au moins deux lignes de thérapie. Cette désignation vise à accélérer le développement et l'examen des médicaments pour des conditions graves présentant des besoins médicaux insatisfaits.
La décision a été soutenue par des données prometteuses de sécurité et d'efficacité issues d'une étude de Phase 1/2 chez des patients fortement prétraités. Le BGB-16673 est le dégradeur de BTK le plus avancé dans les essais cliniques et devrait compléter le BRUKINSA (zanubrutinib) de BeiGene. Plus de 300 patients dans 15 pays ont été traités avec le BGB-16673 dans le cadre de son programme mondial de développement clinique.
Das BGB-16673 von BeiGene, eine orale BTK-targeting chimäre Abbauaktivierungsverbindung (CDAC), hat von der US-amerikanischen FDA die Fast Track Designation für erwachsene Patienten mit rezidivierter oder refraktärer chronischer lymphatischer Leukämie oder kleinem lymphozytären Lymphom (CLL/SLL) erhalten, die zuvor mit mindestens zwei Therapielinien behandelt wurden. Diese Auszeichnung soll die Entwicklung und Überprüfung von Arzneimitteln für schwere Erkrankungen mit ungedecktem medizinischem Bedarf beschleunigen.
Die Entscheidung wurde durch vielversprechende Sicherheits- und Wirksamkeitsdaten aus einer Phase 1/2-Studie bei stark vorbehandelten Patienten unterstützt. BGB-16673 ist der am weitesten fortgeschrittene BTK-Abbaustoff in klinischen Studien und wird voraussichtlich das BRUKINSA (Zanubrutinib) von BeiGene ergänzen. Über 300 Patienten in 15 Ländern wurden im globalen klinischen Entwicklungsprogramm mit BGB-16673 behandelt.
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Designation supported by promising safety and efficacy data from Phase 1/2 study in heavily pretreated patients with relapsed/refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)
The FDA’s Fast track designation is aimed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.
“When disease progression for patients on BTK inhibitors occurs, there is a need for BTK-targeting agents with a different mode of action given the centrality of this pathway in CLL/SLL. BTK-protein degradation with our BTK CDAC (BGB-16673) may address this unmet need,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology. “The FDA’s Fast Track Designation supports our goal of efficiently developing BGB-16673 for these patients, the first investigational drug from our CDAC platform. We believe BGB-16673 strengthens our hematology leadership and complements BRUKINSA (zanubrutinib), the backbone for our investigational hematology pipeline. BGB-16673 is the most advanced BTK degrader in the clinic and is well-suited to become an important therapy for patients progressing after BTKi who have limited options.”
The designation was requested based on the potential for BGB-16673 to address an unmet medical need for patients CLL/SLL whose disease has progressed. Data from ongoing first-in-human Phase 1/2 (NCT05006716) presented at the European Hematology Association 2024 Hybrid Congress in June highlighted the tolerable safety and promising efficacy in heavily pretreated patients with R/R CLL/SLL. More than 300 patients have been treated to date in 15 countries across the BGB-16673 global clinical development program.
About Chronic Lymphocytic Leukemia
A life-threatening cancer of adults, chronic lymphocytic leukemia (CLL) is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow, and lymphoid tissues.1,2 CLL is the most common type of leukemia in adults, accounting for about one-third of new cases of leukemia.2,3 Approximately 20,700 new cases of CLL will be diagnosed in the
About BGB-16673
BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK) targeting chimeric degradation activation compound (CDAC) designed to induce degradation of wildtype and multiple mutant forms of BTK, including those that commonly confer resistance to BTK inhibitors in patients who experience progressive disease.
About BeiGene
BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the ability of BGB-16673 to fulfill an unmet medical need; BeiGene’s ability to efficiently develop BGB-16673; whether BGB-16673 becomes an important therapy for patients progressing after BTKi who have limited options; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the
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1 National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)–Patient Version. Accessed November 2023. https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq.
2 American Cancer Society. What is Chronic Lymphocytic Leukemia? Updated May 10, 2018. Accessed November 2023. https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/what-is-cll.html.
3 American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Updated July 1, 2024. Accessed August 2024. https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/key-statistics.html.
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Source: BeiGene, Ltd.
FAQ
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