{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T08:03:23Z","timestamp":1782288203735,"version":"3.54.5"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T00:00:00Z","timestamp":1759881600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T00:00:00Z","timestamp":1759881600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2025,12]]},"DOI":"10.1007\/s40265-025-02251-4","type":"journal-article","created":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T12:29:14Z","timestamp":1759926554000},"page":"1635-1642","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Lisaftoclax: First Approval"],"prefix":"10.1007","volume":"85","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-1028-8594","authenticated-orcid":false,"given":"Yahiya Y.","family":"Syed","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,10,8]]},"reference":[{"issue":"13","key":"2251_CR1","doi-asserted-by":"publisher","first-page":"2385","DOI":"10.1158\/1078-0432.CCR-22-3321","volume":"29","author":"S Ailawadhi","year":"2023","unstructured":"Ailawadhi S, Chen Z, Huang B, et al. Novel BCL-2 inhibitor lisaftoclax in relapsed or refractory chronic lymphocytic leukemia and other hematologic malignancies: first-in-human open-label trial. Clin Cancer Res. 2023;29(13):2385\u201393.","journal-title":"Clin Cancer Res"},{"issue":"24","key":"2251_CR2","doi-asserted-by":"publisher","first-page":"5455","DOI":"10.1158\/1078-0432.CCR-21-4037","volume":"28","author":"J Deng","year":"2022","unstructured":"Deng J, Paulus A, Fang DD, et al. Lisaftoclax (APG-2575) is a novel BCL-2 inhibitor with robust antitumor activity in preclinical models of hematologic malignancy. Clin Cancer Res. 2022;28(24):5455\u201368.","journal-title":"Clin Cancer Res"},{"key":"2251_CR3","unstructured":"US Food and Drug Administration. VENCLEXTA\u00ae (venetoclax tablets), for oral use: US prescribing information. 2016. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/208573s027lbl.pdf. Accessed 8 Sept 2025."},{"key":"2251_CR4","unstructured":"Ascentage Pharma. Ascentage Pharma announces its novel Bcl-2 inhibitor lisaftoclax approved by China NMPA, ushering in a new era for the treatment of CLL\/SLL [media release]. 10 July 2025. http:\/\/www.ascentage.com."},{"key":"2251_CR5","unstructured":"Ascentage Pharma. Lisaftoclax: Chinese prescribing information [data on file]. 2025."},{"key":"2251_CR6","unstructured":"Ascentage Pharma. Ascentage Pharma\u2019s Bcl-2 inhibitor APG-2575 granted Orphan Drug designation by the FDA for the treatment of chronic lymphocytic leukemia [media release]. 7 Sep 2020. http:\/\/www.ascentagepharma.com."},{"key":"2251_CR7","unstructured":"Ascentage Pharma. Ascentage Pharma announces its 9th Orphan Drug designation from the US FDA in 2020, setting a record for Chinese biopharmaceutical companies [media release]. 4 Jan 2021. http:\/\/www.ascentagepharma.com."},{"key":"2251_CR8","unstructured":"Ascentage Pharma. Ascentage Pharma announces the fifth Orphan Drug designation granted to Bcl-2 inhibitor APG-2575 by the US FDA, and the tenth obtained by the company [media release]. 28 Jan 2021. http:\/\/www.ascentagepharma.com."},{"key":"2251_CR9","unstructured":"Ascentage Pharma. Ascentage Pharma\u2019s Bcl-2 inhibitor APG-2575 granted Orphan Drug designation by the FDA for the treatment of Waldenstr\u00f6m macroglobulinemia [media release]. 15 Jul 2020. http:\/\/www.ascentagepharma.com."},{"key":"2251_CR10","unstructured":"Ascentage Pharma. Ascentage Pharma and AstraZeneca enter into clinical collaboration on the registrational phase III study of Bcl-2 inhibitor lisaftoclax in combination with BTK inhibitor acalabrutinib in treatment-naive patients with first-line CLL\/SLL [media release]. 15 Oct 2023. http:\/\/www.ascentage.com."},{"key":"2251_CR11","unstructured":"Ascentage Pharma. Ascentage Pharma enters clinical collaboration to evaluate the combination of Bcl-2 and BTK inhibitors [media release]. 21 Jun 2020. http:\/\/www.ascentagepharma.com."},{"key":"2251_CR12","unstructured":"Innovent Biologics. Innovent and Ascentage Pharma reach multifaceted strategic agreement including joint commercialization of olverembatinib in China, joint clinical development on multiple products, and equity investment [media release]. 14 Jul 2021. http:\/\/innoventbio.com."},{"key":"2251_CR13","unstructured":"Henlius Biopharmaceuticals. Ascentage Pharma and Henlius form a combination therapy strategic collaboration [media release]. 4 Nov 2019. http:\/\/www.henlius.com."},{"key":"2251_CR14","unstructured":"Ascentage Pharma, MD Anderson Cancer Center. Ascentage Pharma and MD Anderson Cancer Center announce strategic alliance in cancer drug development [media release]. 6 Jan 2019. http:\/\/www.ascentagepharma.com."},{"key":"2251_CR15","unstructured":"Ascentage Pharma. Ascentage Pharma announces clinical trial agreement to evaluate the combination of lisaftoclax (APG-2575) and the CDK4\/6 inhibitor IBRANCE\u00ae (palbociclib) in metastatic ER+\/HER2\u2212 breast cancer [media release]. 8 Nov 2021. http:\/\/www.ascentagepharma.com."},{"issue":"4","key":"2251_CR16","doi-asserted-by":"publisher","first-page":"331","DOI":"10.3727\/096504020X15825405463920","volume":"28","author":"Q Luo","year":"2020","unstructured":"Luo Q, Pan W, Zhou S, et al. A novel BCL-2 inhibitor APG-2575 exerts synthetic lethality with BTK or MDM2-p53 inhibitor in diffuse large B-cell lymphoma. Oncol Res. 2020;28(4):331\u201344.","journal-title":"Oncol Res"},{"issue":"299","key":"2251_CR17","first-page":"1","volume":"20","author":"W Wei","year":"2022","unstructured":"Wei W, Huang S, Ling Q, et al. Homoharringtonine is synergistically lethal with BCL-2 inhibitor APG-2575 in acute myeloid leukemia. J Transl Med. 2022;20(299):1\u201312.","journal-title":"J Transl Med"},{"key":"2251_CR18","doi-asserted-by":"crossref","unstructured":"Peng B, Xiong Y, Liang ZY, et al. Effects of olverembatinib (HQP1351) in combination with BCL-2 inhibitor lisaftoclax (APG-2575) in T-cell acute lymphoblastic leukemia (T-ALL) [abstract no. 5648]. Cancer Res. 2025;85(8 Suppl 1).","DOI":"10.1158\/1538-7445.AM2025-5648"},{"key":"2251_CR19","doi-asserted-by":"crossref","unstructured":"Xiong Y, Liang ZY, Min P, et al. Olverembatinib (HQP1351) in combination with lisaftoclax (APG2575) overcomes venetoclax resistance in preclinical models of acute myeloid leukemia (AML) [abstract no. 5652]. Cancer Res. 2025;85(8 Suppl 1).","DOI":"10.1158\/1538-7445.AM2025-5652"},{"issue":"1","key":"2251_CR20","doi-asserted-by":"publisher","first-page":"60","DOI":"10.1038\/s41423-023-01112-y","volume":"21","author":"F Luo","year":"2024","unstructured":"Luo F, Li H, Ma W, et al. The BCL-2 inhibitor APG-2575 resets tumor-associated macrophages toward the M1 phenotype, promoting a favorable response to anti-PD-1 therapy via NLRP3 activation. Cell Mol Immunol. 2024;21(1):60\u201379.","journal-title":"Cell Mol Immunol"},{"issue":"Suppl 1","key":"2251_CR21","doi-asserted-by":"publisher","first-page":"3730","DOI":"10.1182\/blood-2021-152235","volume":"138","author":"M Sun","year":"2021","unstructured":"Sun M, Qi J, Chen Z, et al. A phase 1 study to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of lisaftoclax (APG-2575), a novel bcl-2 inhibitor (BCL-2i), in patients (pts) with certain relapsed or refractory (R\/R) hematologic malignancies (HMs) [abstract]. Blood. 2021;138(Suppl 1):3730.","journal-title":"Blood"},{"issue":"Suppl 1","key":"2251_CR22","doi-asserted-by":"publisher","first-page":"4614","DOI":"10.1182\/blood-2024-207408","volume":"144","author":"MS Davids","year":"2024","unstructured":"Davids MS, Ailawadhi S, Chanan-Khan AA, et al. Lisaftoclax (APG-2575) demonstrates activity and safety when given with accelerated ramp-up and then combined with acalabrutinib or rituximab in patients (pts) with chronic lymphocytic leukemia\/small lymphocytic lymphoma (CLL\/SLL), including those with prior exposure to venetoclax [abstract]. Blood. 2024;144(Suppl 1):4614\u20136.","journal-title":"Blood"},{"key":"2251_CR23","doi-asserted-by":"crossref","unstructured":"Lasica M, Ailawadhi S, Fu C, et al. Updated efficacy and safety results of BCL-2 inhibitor lisaftoclax (APG-2575) alone or combined with ibrutinib or rituximab in patients (pts) with Waldenstrom macroglobulinemia (WM) [abstract no. 7078]. J Clin Oncol. 2024;42(16 Suppl).","DOI":"10.1200\/JCO.2024.42.16_suppl.7078"},{"issue":"Suppl 1","key":"2251_CR24","first-page":"1023","volume":"144","author":"S Ailawadhi","year":"2024","unstructured":"Ailawadhi S, Chanan-Khan AA, Khouri J, et al. Lisaftoclax (APG-2575) combined with novel therapeutic regimens in patients (pts) with relapsed or refractory multiple myeloma (R\/R MM) or immunoglobulin light-chain (AL) amyloidosis [abstract]. Blood. 2024;144(Suppl 1):1023.","journal-title":"Blood"},{"issue":"Suppl 1","key":"2251_CR25","doi-asserted-by":"publisher","first-page":"2326","DOI":"10.1182\/blood-2022-160386","volume":"140","author":"MS Davids","year":"2022","unstructured":"Davids MS, Chanan-Khan A, Mudenda B, et al. Lisaftoclax (APG-2575) safety and activity as monotherapy or combined with acalabrutinib or rituximab in patients (pts) with treatment-naive, relapsed or refractory chronic lymphocytic leukemia\/small lymphocytic lymphoma (R\/R CLL\/SLL): initial data from a phase 2 global study [abstract]. Blood. 2022;140(Suppl 1):2326\u20138.","journal-title":"Blood"},{"key":"2251_CR26","doi-asserted-by":"crossref","unstructured":"Li J, Zhou K, Nian W, et al. A phase Ib\/II study of lisaftoclax (APG-2575), a novel BCL-2 inhibitor (BCL-2i), in patients (pts) with relapsed\/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R\/R CLL\/SLL) [abstract no. 7543]. J Clin Oncol. 2022;40(16 Suppl).","DOI":"10.1200\/JCO.2022.40.16_suppl.7543"},{"issue":"Suppl 1","key":"2251_CR27","doi-asserted-by":"publisher","first-page":"1900","DOI":"10.1182\/blood-2023-183071","volume":"142","author":"KS Zhou","year":"2023","unstructured":"Zhou KS, Sun MY, Wei X, et al. Updated efficacy and safety results of lisaftoclax (APG-2575) in patients (pts) with heavily pretreated chronic lymphocytic leukemia (CLL): pooled analyses of two clinical trials [abstract plus poster]. Blood. 2023;142(Suppl 1):1900.","journal-title":"Blood"},{"key":"2251_CR28","doi-asserted-by":"publisher","first-page":"996","DOI":"10.1097\/01.HS9.0000847292.19961.d6","volume":"6","author":"M Sun","year":"2022","unstructured":"Sun M, Qi J, Song Y, et al. Preliminary results of a phase 1 study of novel BCL-2 inhibitor lisaftoclax (APG-2575) in Chinese patients (pts) with relapsed or refractory (R\/R) non-Hodgkin lymphomas (NHLS) [poster P1106]. HemaSphere. 2022;6:996\u20137.","journal-title":"HemaSphere"},{"key":"2251_CR29","doi-asserted-by":"crossref","unstructured":"Leahy MF, Fleming S, Kropf P, et al. Phase 1b\/2 study of lisaftoclax (APG-2575) combined with azacitidine (AZA) in patients (pts) with treatment-na\u00efve (TN) or prior venetoclax (VEN)-exposed myeloid malignancies [abstract no. 6505]. J Clin Oncol. 2025;43(16 Suppl).","DOI":"10.1200\/JCO.2025.43.16_suppl.6505"},{"key":"2251_CR30","doi-asserted-by":"crossref","unstructured":"Wang H, Wei X, Liang Y, et al. Safety and efficacy of lisaftoclax, a novel BCL-2 inhibitor, in combination with azacitidine in patients with treatment-naive or relapsed or refractory acute myeloid leukemia [abstract no. 6541]. J Clin Oncol. 2024;42(16 Suppl).","DOI":"10.1200\/JCO.2024.42.16_suppl.6541"},{"issue":"Suppl 1","key":"2251_CR31","doi-asserted-by":"publisher","first-page":"3202","DOI":"10.1182\/blood-2024-205371","volume":"144","author":"HF Wang","year":"2024","unstructured":"Wang HF, Wei XD, Liang Y, et al. Lisaftoclax (APG-2575), a novel BCL-2 inhibitor, in combination with azacitidine in treatment of patients with myelodysplastic syndrome (MDS) [abstract]. Blood. 2024;144(Suppl 1):3202\u20133.","journal-title":"Blood"}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-025-02251-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40265-025-02251-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-025-02251-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,13]],"date-time":"2025-11-13T14:34:10Z","timestamp":1763044450000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40265-025-02251-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,8]]},"references-count":31,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["2251"],"URL":"https:\/\/doi.org\/10.1007\/s40265-025-02251-4","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,8]]},"assertion":[{"value":"8 September 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 September 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 October 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Yahiya Y. Syed is a salaried employee of Adis International Ltd\/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authorship and Conflict of Interest"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval, Consent to Participate, Consent to Publish, Availability of Data and Material, Code Availability"}}]}}