A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients

The goal of Phase 1a of this clinical research study is to find the highest tolerable dose of revumenib that can be given in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin to patients who have acute leukemia.
The goal of Phase 1b of this clinical research study is to learn if the dose of revumenib in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin found in Phase 1a can help to control the disease.

开始日期2025-12-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT07212023

/ Not yet recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia With a KMT2A or NUP98 Gene Rearrangement (REVEAL-ND KMT2A)

The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with acute myeloid leukemia (AML) with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy

开始日期2025-12-01

申办/合作机构

Syndax Pharmaceuticals, Inc.

NCT07211958

/ Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation

The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.

开始日期2025-11-25

申办/合作机构

Syndax Pharmaceuticals, Inc.

100 项与瑞维美尼相关的临床结果

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100 项与瑞维美尼相关的转化医学

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100 项与瑞维美尼相关的专利（医药）

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项与瑞维美尼相关的文献（医药）

2026-01-15·INTERNATIONAL JOURNAL OF CANCER

Targeting the Menin–KMT2A interaction in leukemia: Lessons learned and future directions

Review

作者: Florian Perner ; Jayant Y. Gadrey ; Michael W. M. Kühn ; Scott A. Armstrong

Abstract:

Chromosomal rearrangements involving the Mixed Lineage Leukemia gene ( MLL1 , KMT2A ) are defining a genetically distinct subset in about 10% of human acute leukemias. Translocations involving the KMT2A ‐locus at chromosome 11q23 are resulting in the formation of a chimeric oncogene, where the N‐terminal part of KMT2A is fused to a variety of translocation partners. The most frequently found fusion partners of KMT2A in acute leukemia are the C‐terminal parts of AFF1, MLLT3, MLLT1 and MLLT10. Unfortunately, the presence of an KMT2A‐rearrangements is associated with adverse outcomes in leukemia patients. Moreover, non‐rearranged KMT2A‐complexes have been demonstrated to be crucial for disease development and maintenance in NPM1‐mutated and NUP98‐rearranged leukemia, expanding the spectrum of genetic disease subtypes that are dependent on KMT2A . Recent advances in the development of targeted therapy strategies to disrupt the function of KMT2A‐complexes in leukemia have led to the establishment of Menin–KMT2A interaction inhibitors that effectively eradicate leukemia in preclinical model systems and show favorable tolerability and significant efficacy in early‐phase clinical trials. Indeed, one Menin inhibitor, Revumenib, was recently approved for the treatment of patients with relapsed or refractory KMT2A‐rearranged acute leukemia. However, single agent therapy can lead to resistance. In this Review article we summarize our current understanding about the biology of pathogenic KMT2A‐complex function in cancer, specifically leukemia, and give a systematic overview of lessons learned from recent clinical and preclinical studies using Menin inhibitors.

2025-12-01·Cell Reports

Menin-MLL1 complex cooperates with NF-Y to promote hepatocellular carcinoma survival

Article

作者: Dzama-Karels, Margarita ; Raab, Jesse R ; Brinkman, Jacqueline A ; Kuhlers, Peyton ; Morris, John P ; Sokolowski, Mallory

Chromatin regulators are frequently mutated or aberrantly expressed in hepatocellular carcinoma (HCC), suggesting that the dysregulation of chromatin is a key feature driving liver cancer. In this study, using an epigenome-focused CRISPR screen in two-dimensional (2D) and three-dimensional (3D) conditions, we find the subunits of the menin-MLL1 complex to be among the strongest candidates for HCC survival. Inhibition of the menin-MLL1 interaction leads to global changes in occupancy of the complex with concomitant decreases in H3 lysine 4 trimethylation (H3K4me3), accessibility, and gene expression. Newly opened chromatin sites not bound by menin-MLL1 are associated with the recruitment of the pioneer transcription factor complex NF-Y yet remain embedded in silent chromatin domains, suggesting that they are primed for expression. A CRISPR-Cas9 screen of chromatin regulators in the presence of menin inhibitor SNDX-5613 reveals a significantly increased cell death when combined with NFYB knockout. Together, these data show that menin-MLL1 is necessary for HCC cell survival and cooperates with NF-Y to regulate oncogenic gene transcription.

2025-12-01·ANNALS OF PHARMACOTHERAPY

Revumenib for Relapsed or Refractory Acute Leukemia With a KMT2A Translocation

Review

作者: Faro, Sarah Jane E. ; Lynch, Emilie J. ; Lindstrom, Alec M. ; Sethi, Nadia A. ; Seligson, Nathan D. ; Wang, Wendy Y.

Objective::

To review the pharmacology, efficacy, and safety of revumenib (Revuforj) for relapsed or refractory (r/r) acute leukemia with a lysine methyltransferase 2A ( KMT2A) gene rearrangement or translocation ( KMT2Ar ).

Data Sources::

A literature search was conducted using PubMed/MEDLINE, applicable published abstracts, and ongoing studies from ClinicalTrials.gov between January 1, 1981, and April 23, 2025. Keywords included Revuforj, revumenib, SNDX-5613, KMT2A , MLL1 , and menin.

Study Selection and Data Extraction::

All English-language studies involving revumenib for r/r acute leukemia with a KMT2Ar were included.

Data Synthesis::

Revumenib, a protein-protein inhibitor that interrupts the interaction between the KMT2A protein and the scaffold protein menin, was granted approval by the Food and Drug Administration (FDA) for r/r acute leukemia with KMT2Ar based on a phase 2 clinical trial in adult and pediatric patients (n = 57), which reported a complete remission or complete remission with partial hematologic recovery of 22.8%. Common grade 3/4 adverse reactions reported for revumenib include infectious (febrile neutropenia 33%; infection 29%; bacterial infection 20%) and hematologic events (differentiation syndrome 13%; hemorrhage 9%; thrombosis 5%). Grade 3/4 QT prolongation, the primary dose-limiting adverse effect, was present in 12% of patients. Differentiation syndrome, related to revumenib’s antileukemic effect, was observed in 29% of patients (grade 3/4: 13%; grade 5: <1%). We also include long-term follow-up for a total of 104 and 135 patients for efficacy and safety results, respectively.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs::

In the high-risk disease of r/r acute leukemia with KMT2Ar , given limited treatment options, revumenib appears to be a viable, novel treatment option demonstrating clinical efficacy and a manageable adverse effect profile that can be utilized as a bridge to stem cell transplant. Existing therapy options in this setting may include additional traditional chemotherapy, chimeric antigen receptor T-cell therapy (CAR-T), antibody-drug conjugates (eg, gemtuzumab, inotuzumab), bispecific T-cell engager (BiTE) therapies (eg, blinatumomab), DNA methyltransferase inhibitors (eg, azacitidine, decitabine), histone deacetylase inhibitors (eg, vorinostat, panobinostat), and BCL-2 inhibitors (venetoclax).

Conclusions::

Revumenib is an innovative targeted treatment with promising activity in r/r acute leukemia with KMT2Ar .

258

项与瑞维美尼相关的新闻（医药）

2025-12-06

·LONGPORT

Syndax 制药公司 $SNDX 的股票被 Tema Etfs LLC 收购

Tema Etfs LLC 在第二季度将其在 Syndax Pharmaceuticals 的股份增加了 307.7%，持有 86,301 股，价值 808,000 美元。其他投资者也增加了他们的持股。Syndax 的股票上涨了 2.9%，市值为 17.7 亿美元。分析师的评级不一，普遍共识为 “适度买入”，平均目标价为 37.20 美元。首席执行官 Michael Metzger 出售了价值 258 万美元的股份Tema Etfs LLC 在最近向证券交易委员会（SEC）提交的文件中表示，在第二季度将其在 Syndax Pharmaceuticals, Inc.（NASDAQ:SNDX - 免费报告）的股份增加了 307.7%。该机构投资者在本季度额外收购了 65,132 股后，持有该公司 86,301 股股票。Tema Etfs LLC 在最近一个季度末持有 Syndax Pharmaceuticals 约 0.10% 的股份，价值 808,000 美元。获取 Syndax Pharmaceuticals 的提醒：其他大型投资者最近也买卖了该公司的股票。富兰克林资源公司在第二季度将其在 Syndax Pharmaceuticals 的股份增加了 14.5%。富兰克林资源公司现在拥有 2,359,677 股该公司的股票，价值 22,098,000 美元，此前在上个季度额外购买了 298,272 股。Geode Capital Management LLC 在第二季度将其在 Syndax Pharmaceuticals 的股份增加了 1.3%。Geode Capital Management LLC 现在拥有 2,049,350 股该公司的股票，价值 19,195,000 美元，此前在此期间额外购买了 26,365 股。Aisling Capital Management LP 在第二季度将其在 Syndax Pharmaceuticals 的股份增加了 28.5%。Aisling Capital Management LP 现在拥有 1,316,806 股该公司的股票，价值 12,325,000 美元，此前在上个季度额外购买了 291,806 股。Algert Global LLC 在第一季度将其在 Syndax Pharmaceuticals 的持股增加了 12.6%。Algert Global LLC 现在拥有 884,600 股该公司的股票，价值 10,867,000 美元，此前在此期间额外收购了 98,968 股。最后，Candriam S.C.A. 在第二季度将其在 Syndax Pharmaceuticals 的持股增加了 49.9%。Candriam S.C.A. 现在拥有 675,085 股该公司的股票，价值 6,322,000 美元，此前在此期间额外收购了 224,650 股。 Syndax Pharmaceuticals 股票上涨 2.9% SNDX 周五开盘价为 20.32 美元。该公司的债务与股本比率为 2.78，流动比率为 4.64，速动比率为 4.42。Syndax Pharmaceuticals, Inc. 的 12 个月最低价为 8.58 美元，最高价为 20.59 美元。该股票的市值为 17.7 亿美元，市盈率为 -5.63，贝塔值为 0.48。该公司的 50 日简单移动平均线为 16.30 美元，200 日简单移动平均线为 13.57 美元。 Syndax Pharmaceuticals（NASDAQ:SNDX - 获取免费报告）上次发布季度财报是在 11 月 3 日星期一。该公司报告的每股收益（EPS）为（0.70）美元，超过了市场共识预期的（0.74）美元，超出 0.04 美元。该公司在本季度的收入为 4587 万美元，而分析师预期为 4908 万美元。Syndax Pharmaceuticals 的股本回报率为 -160.60%，净利润率为 -279.31%。与去年同期相比，Syndax Pharmaceuticals 的收入增长了 266.4%。在去年同期，该公司每股收益为（0.98）美元。平均而言，股票分析师预计 Syndax Pharmaceuticals, Inc. 在当前财政年度的每股收益将为 -3.72 美元。华尔街分析师预测增长几家研究公司最近对 SNDX 进行了评论。巴克莱将 Syndax Pharmaceuticals 的股票目标价从 22.00 美元上调至 35.00 美元，并在 11 月 24 日的研究报告中给予该公司 “增持” 评级。高盛集团将 Syndax Pharmaceuticals 的股票目标价从 20.00 美元上调至 24.00 美元，并在 9 月 5 日的报告中给予该公司 “买入” 评级。韦斯评级在周一的研究报告中重申了对 Syndax Pharmaceuticals 的 “卖出（d-）” 评级。斯蒂费尔·尼古拉斯在 9 月 10 日的研究报告中启动了对 Syndax Pharmaceuticals 的覆盖。他们给予该股票 “买入” 评级，并设定了 44.00 美元的目标价。最后，华尔街 Zen 在周六的研究报告中将 Syndax Pharmaceuticals 的评级从 “持有” 下调至 “卖出”。一位研究分析师对该股票给予了强烈买入评级，九位分析师给予了买入评级，一位分析师给予了持有评级，一位分析师给予了卖出评级。根据 MarketBeat 的数据，Syndax Pharmaceuticals 目前的共识评级为 “适度买入”，平均目标价为 37.20 美元。阅读我们最新的 SNDX 股票分析内部人士下注在其他新闻中，首席执行官 Michael A. Metzger 在 9 月 8 日星期一出售了 157,307 股该公司的股票。该股票以平均价格 16.41 美元出售，总交易额为 2,581,407.87 美元。出售后，首席执行官持有 298,661 股该公司的股票，价值 4,901,027.01 美元。此次交易使其持股减少了 34.50%。该交易已在向证券交易委员会的法律文件中披露，相关文件可通过此链接获取。内部人士持有该公司 4.10% 的股份。 Syndax Pharmaceuticals 简介（免费报告） Syndax Pharmaceuticals, Inc. 是一家临床阶段的生物制药公司，开发用于癌症治疗的疗法。其主要产品候选药物包括 revumenib，一种强效、选择性的、针对 menin-MLL 结合相互作用的小分子抑制剂，用于治疗 KMT2A 重排的急性白血病和实体瘤；以及 SNDX-6352 或 axatilimab，一种单克隆抗体，阻断集落刺激因子 1（CSF-1）受体，用于治疗慢性移植物抗宿主病（cGVHD）和特发性肺纤维化（IPF）患者。了解更多五只我们更看好的股票，胜过 Syndax Pharmaceuticals NYSE 股票为投资者提供多种优质选择比尔和梅琳达·盖茨基金会出售 MSFT 股票——投资者应该担心吗？高飞者：2022 年 3 月的 3 只天然气股票 MarketBeat 周回顾 – 12/1 - 12/5 深入了解买卖差价 Rocket Lab 的大反弹？分析师建议此次下跌是个机会此即时新闻提醒由叙述科学技术和 MarketBeat 的金融数据生成，旨在为读者提供最快的报道和公正的覆盖。请将任何问题或意见发送至 contact@marketbeat.com. 你现在应该投资 1,000 美元在 Syndax Pharmaceuticals 吗？在你考虑 Syndax Pharmaceuticals 之前，你需要听听这个。 MarketBeat 每天跟踪华尔街顶级评级和表现最佳的研究分析师及其推荐给客户的股票。MarketBeat 已识别出五只顶级分析师悄悄建议客户现在购买的股票，以便在更广泛的市场注意到之前……而 Syndax Pharmaceuticals 并不在名单上。虽然 Syndax Pharmaceuticals 目前在分析师中有中等买入评级，但顶级分析师认为这五只股票更值得购买。在这里查看这五只股票 Tema Etfs LLC 在最近向证券交易委员会（SEC）提交的文件中表示，在第二季度将其在 Syndax Pharmaceuticals, Inc.（NASDAQ:SNDX - 免费报告）的股份增加了 307.7%。该机构投资者在本季度额外收购了 65,132 股后，持有该公司 86,301 股股票。Tema Etfs LLC 在最近一个季度末持有 Syndax Pharmaceuticals 约 0.10% 的股份，价值 808,000 美元。获取 Syndax Pharmaceuticals 的提醒：其他大型投资者最近也买卖了该公司的股票。富兰克林资源公司在第二季度将其在 Syndax Pharmaceuticals 的股份增加了 14.5%。富兰克林资源公司现在拥有 2,359,677 股该公司的股票，价值 22,098,000 美元，此前在上个季度额外购买了 298,272 股。Geode Capital Management LLC 在第二季度将其在 Syndax Pharmaceuticals 的股份增加了 1.3%。Geode Capital Management LLC 现在拥有 2,049,350 股该公司的股票，价值 19,195,000 美元，此前在此期间额外购买了 26,365 股。Aisling Capital Management LP 在第二季度将其在 Syndax Pharmaceuticals 的股份增加了 28.5%。Aisling Capital Management LP 现在拥有 1,316,806 股该公司的股票，价值 12,325,000 美元，此前在上个季度额外购买了 291,806 股。Algert Global LLC 在第一季度将其在 Syndax Pharmaceuticals 的持股增加了 12.6%。Algert Global LLC 现在拥有 884,600 股该公司的股票，价值 10,867,000 美元，此前在此期间额外收购了 98,968 股。最后，Candriam S.C.A. 在第二季度将其在 Syndax Pharmaceuticals 的持股增加了 49.9%。Candriam S.C.A. 现在拥有 675,085 股该公司的股票，价值 6,322,000 美元，此前在此期间额外收购了 224,650 股。 Syndax Pharmaceuticals 股票上涨 2.9% SNDX 周五开盘价为 20.32 美元。该公司的债务与股本比率为 2.78，流动比率为 4.64，速动比率为 4.42。Syndax Pharmaceuticals, Inc. 的 12 个月最低价为 8.58 美元，最高价为 20.59 美元。该股票的市值为 17.7 亿美元，市盈率为 -5.63，贝塔值为 0.48。该公司的 50 日简单移动平均线为 16.30 美元，200 日简单移动平均线为 13.57 美元。 Syndax Pharmaceuticals（NASDAQ:SNDX - 获取免费报告）上次发布季度财报是在 11 月 3 日星期一。该公司报告的每股收益（EPS）为（0.70）美元，超过了市场共识预期的（0.74）美元，超出 0.04 美元。该公司在本季度的收入为 4587 万美元，而分析师预期为 4908 万美元。Syndax Pharmaceuticals 的股本回报率为 -160.60%，净利润率为 -279.31%。与去年同期相比，Syndax Pharmaceuticals 的收入增长了 266.4%。在去年同期，该公司每股收益为（0.98）美元。平均而言，股票分析师预计 Syndax Pharmaceuticals, Inc. 在当前财政年度的每股收益将为 -3.72 美元。华尔街分析师预测增长几家研究公司最近对 SNDX 进行了评论。巴克莱将 Syndax Pharmaceuticals 的股票目标价从 22.00 美元上调至 35.00 美元，并在 11 月 24 日的研究报告中给予该公司 “增持” 评级。高盛集团将 Syndax Pharmaceuticals 的股票目标价从 20.00 美元上调至 24.00 美元，并在 9 月 5 日的报告中给予该公司 “买入” 评级。韦斯评级在周一的研究报告中重申了对 Syndax Pharmaceuticals 的 “卖出（d-）” 评级。斯蒂费尔·尼古拉斯在 9 月 10 日的研究报告中启动了对 Syndax Pharmaceuticals 的覆盖。他们给予该股票 “买入” 评级，并设定了 44.00 美元的目标价。最后，华尔街 Zen 在周六的研究报告中将 Syndax Pharmaceuticals 的评级从 “持有” 下调至 “卖出”。一位研究分析师对该股票给予了强烈买入评级，九位分析师给予了买入评级，一位分析师给予了持有评级，一位分析师给予了卖出评级。根据 MarketBeat 的数据，Syndax Pharmaceuticals 目前的共识评级为 “适度买入”，平均目标价为 37.20 美元。阅读我们最新的 SNDX 股票分析内部人士下注在其他新闻中，首席执行官 Michael A. Metzger 在 9 月 8 日星期一出售了 157,307 股该公司的股票。该股票以平均价格 16.41 美元出售，总交易额为 2,581,407.87 美元。出售后，首席执行官持有 298,661 股该公司的股票，价值 4,901,027.01 美元。此次交易使其持股减少了 34.50%。该交易已在向证券交易委员会的法律文件中披露，相关文件可通过此链接获取。内部人士持有该公司 4.10% 的股份。 Syndax Pharmaceuticals 简介（免费报告） Syndax Pharmaceuticals, Inc. 是一家临床阶段的生物制药公司，开发用于癌症治疗的疗法。其主要产品候选药物包括 revumenib，一种强效、选择性的、针对 menin-MLL 结合相互作用的小分子抑制剂，用于治疗 KMT2A 重排的急性白血病和实体瘤；以及 SNDX-6352 或 axatilimab，一种单克隆抗体，阻断集落刺激因子 1（CSF-1）受体，用于治疗慢性移植物抗宿主病（cGVHD）和特发性肺纤维化（IPF）患者。了解更多五只我们更看好的股票，胜过 Syndax Pharmaceuticals NYSE 股票为投资者提供多种优质选择比尔和梅琳达·盖茨基金会出售 MSFT 股票——投资者应该担心吗？高飞者：2022 年 3 月的 3 只天然气股票 MarketBeat 周回顾 – 12/1 - 12/5 深入了解买卖差价 Rocket Lab 的大反弹？分析师建议此次下跌是个机会此即时新闻提醒由叙述科学技术和 MarketBeat 的金融数据生成，旨在为读者提供最快的报道和公正的覆盖。请将任何问题或意见发送至 contact@marketbeat.com. 你现在应该投资 1,000 美元在 Syndax Pharmaceuticals 吗？在你考虑 Syndax Pharmaceuticals 之前，你需要听听这个。 MarketBeat 每天跟踪华尔街顶级评级和表现最佳的研究分析师及其推荐给客户的股票。MarketBeat 已识别出五只顶级分析师悄悄建议客户现在购买的股票，以便在更广泛的市场注意到之前……而 Syndax Pharmaceuticals 并不在名单上。虽然 Syndax Pharmaceuticals 目前在分析师中有中等买入评级，但顶级分析师认为这五只股票更值得购买。在这里查看这五只股票

并购财报临床1期

2025-12-06

·今日头条

在白血病治疗的角逐中，科技的每一次突破都带来希望。特别是AML-M5型的患者，过去因化疗副作用而放弃治疗的经历，揭示了传统方案的局限。而现在，最新的药物研发给出了一线曙光。2023年FDA批准的revumenib，成为首个针对KMT2A重排的口服药物，为难治性复发患者打开了新途径。中国药监局也

在白血病治疗的角逐中，科技的每一次突破都带来希望。特别是AML-M5型的患者，过去因化疗副作用而放弃治疗的经历，揭示了传统方案的局限。而现在，最新的药物研发给出了一线曙光。2023年FDA批准的revumenib，成为首个针对KMT2A重排的口服药物，为难治性复发患者打开了新途径。中国药监局也在推动吉瑞替尼的适应症延伸，国内患者或许很快就能享受到这类靶向药的福音。更令人振奋的是，CAR-T疗法的临床试验数据让人看到个体化免疫治疗的潜力。52%的缓解率或许预示着，未来AML治疗不再只是“拼化疗”的战场，而是多条线并进的未来。尽管诱导化疗仍是主流，但越来越多的研究正逐步改善副作用管理，让患者能在治疗中保持生活质量。我曾见过不少患者在化疗后苦苦挣扎，副作用像无形的枷锁。如今，医生开始注重“细节之美”，用新药和辅助方案，让治疗更温和、更个性化。这一切都在提醒我们，未来的白血病治疗，不是简单的药物堆叠，而是科学与人文的深度结合。愿每位患者都能在科技的护佑下，迎来真正的康复之日。

2025-12-03

·PRNewswire

Florida Cancer Specialists & Research Institute Contributing To Breakthroughs In Treatment of Blood Cancers & Disorders

FORT MYERS, Fla., Dec. 3, 2025 /PRNewswire/ -- Results of eleven research studies conducted with participation from Florida Cancer Specialists & Research Institute, LLC (FCS) were selected for presentation at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando. The gathering is regarded as the leading global meeting for top researchers and clinicians driving innovation in the treatment of blood cancers and blood disorders. "Our commitment to discovery has yielded significant milestones in advancing the next generation of therapies for blood cancers and other hematologic conditions," said FCS President & Managing Physician Lucio N. Gordan, MD. One of the nation's most extensive community-based oncology research programs, FCS provides access to advanced clinical trials across 29 locations in Florida, including three early-phase drug development units (DDUs). The majority of new cancer drugs approved in recent years for use in the U.S. underwent clinical trials involving FCS participation before gaining approval. FCS was one of the initial two sites involved in the Phase 1 trial of pirtobrutinib, now regarded as a best-in-class targeted therapy for several blood cancers and the first next-generation BTK inhibitor approved by the U.S. Food & Drug Administration (FDA) in 2023 for mantle cell lymphoma (MCL), followed shortly by approvals for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). In 2024, the FDA approved revumenib—a revolutionary therapy for relapsed or refractory acute leukemia—after it was first administered to an FCS patient. Manish Patel, MD, FCS Director of Drug Development, has co-authored several abstracts on pirtobrutinib, including two selected for presentation at the ASH annual meeting: Pirtobrutinib in Relapsed/Refractory (R/R) Waldenström macroglobulinemia (WM): Up to 5 years of follow-up from the Phase 1/2 BRUIN study Pirtobrutinib in post-cbtki CLL/SLL: Final update from the Phase 1/2 BRUIN study with more than 5 years follow-up Additionally, the following FCS hematologists and medical oncologists are co-authors of abstracts that will be presented in oral or poster presentations: Gustavo Fonseca, MD, FACP, FCS Director of Research & Clinical Trials ANKRD26-related thrombocytopenia: Hematologic malignancy characteristics, clinical outcomes, and precursor states Asciminib (ASC) in chronic myeloid leukemia in chronic Phase (CML-CP): Interim analysis (IA) efficacy and safety results of the Phase 2 ASC2ESCALATE trial in the cohort of newly diagnosed (1L) patients (pts) Shachar Peles, MD, FCS Director of Cell Therapy Fixed treatment duration subcutaneous mosunetuzumab monotherapy in elderly/unfit patients with previously untreated diffuse large B-cell lymphoma: Interim results from the Phase II MorningSun study Jeffrey Bubis, DO, FACOI, FACP Optimizing processes for adverse event management for bispecific antibodies for diffuse large b-cell lymphoma in community practice: Insights from a quality improvement initiative Jennifer Cultrera, MD Zanubrutinib is well tolerated and effective in acalabrutinib-intolerant patients with B-cell malignancies: A long-term follow-up Uma Iyer, MD Evaluating the effect of morbid obesity on DVT in patients already on doac therapy: A retrospective analysis Mahender Yellu, MD, MBBS, MHA Nationwide impact of CAR-T approval on acute lymphoblastic leukemia mortality in the United States, 1999-2023: Difference-in-differences and synthetic control analyses Syed Zafar, MD: Deep responses and durable outcomes in patients treated with belantamab mafodotin plus pomalidomide and dexamethasone from long-term follow-up of the Phase 3 dreamm-8 study Functional high-risk relapsed/refractory multiple myeloma (RRMM) outcomes with belantamab mafodotin (belamaf): Dreamm-7 and dreamm-8 subgroup analysis A comprehensive list of abstracts presented at the 2025 ASH Annual Meeting and Exposition can be found here: ASH Annual Meeting Abstracts. Over 110 new early-phase and 40 late-phase studies are launched annually at FCS in partnership with Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials. Additionally, a partnership with Paradigm Health, Inc. aids in streamlining and accelerating patient matching to available clinical trials. To learn more about clinical trials offered at FCS, visit: About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. In fact, before receiving FDA approval, the majority of new cancer drugs in the U.S. were first made available to patients through participation in clinical trials at FCS. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. SOURCE Florida Cancer Specialists & Research Institute 21% more press release views with Request a Demo

临床2期临床结果上市批准ASH会议临床1期

100 项与瑞维美尼相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
NPM1突变急性髓系白血病	美国	Syndax Pharmaceuticals, Inc.	2025-10-24
KMT2A易位的急性白血病	美国	Syndax Pharmaceuticals, Inc.	2024-11-15

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
结直肠癌	临床2期	美国	Syndax Pharmaceuticals, Inc.	2023-04-04
急性淋巴细胞白血病	临床2期	美国	Syndax Pharmaceuticals, Inc.	2019-11-05
急性淋巴细胞白血病	临床2期	澳大利亚	Syndax Pharmaceuticals, Inc.	2019-11-05
急性淋巴细胞白血病	临床2期	加拿大	Syndax Pharmaceuticals, Inc.	2019-11-05
急性淋巴细胞白血病	临床2期	法国	Syndax Pharmaceuticals, Inc.	2019-11-05
急性淋巴细胞白血病	临床2期	德国	Syndax Pharmaceuticals, Inc.	2019-11-05
急性淋巴细胞白血病	临床2期	以色列	Syndax Pharmaceuticals, Inc.	2019-11-05
急性淋巴细胞白血病	临床2期	意大利	Syndax Pharmaceuticals, Inc.	2019-11-05
急性淋巴细胞白血病	临床2期	立陶宛	Syndax Pharmaceuticals, Inc.	2019-11-05
急性淋巴细胞白血病	临床2期	荷兰	Syndax Pharmaceuticals, Inc.	2019-11-05

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04065399 (AUGMENT-101, EHA2025)	临床2期	急性白血病	116	Revumenib 163 mg	簾鹽憲糧夢壓餘築膚獵(襯襯顧窪積顧淵艱憲鹹) = 選壓觸衊網齋鏇壓衊顧餘艱選顧範構繭願蓋鏇 (鹹簾願膚願簾憲餘製衊, 54 ~ 73) 更多	积极	2025-05-14
NCT04065399 (AUGMENT-101, EHA2025)	临床1期	急性白血病 NUP98r	34	Revumenib	窪糧膚鹽夢糧壓築選壓(膚鏇觸衊積醖糧築鬱鏇) = 鹹簾選憲壓網鏇鹽襯齋鹽衊願襯鏇襯餘鬱夢範 (壓鹹鏇積鬱醖蓋顧築範 ) 更多	积极	2025-05-14
NCT04065399 (AUGMENT-101, EHA2025)	临床2期	NPM1突变急性髓系白血病	84	Revumenib 160 mg	齋齋膚憲鹹糧餘鹽範夢(齋餘選積觸鏇鹽願鬱遞) = 憲夢鏇窪餘蓋襯窪積繭鹹製鑰遞鬱鏇獵衊蓋蓋 (淵觸艱獵廠顧夢齋製製, 36.5% ~ 59.7) 更多	积极	2025-05-14
NCT04065399 (AUGMENT-101, Company_Website \| Pubmed) 人工标引	临床2期	NPM1突变急性髓系白血病 NPM1 Mutation	84	Revumenib	觸衊顧鑰鬱簾積築獵衊(構築蓋獵窪獵糧鹽選艱) = 鏇廠獵壓獵壓鹽齋夢醖淵醖簾鏇選艱鬱網鑰糧 (鬱憲願觸範獵衊築製壓, 14 ~ 36) 更多	积极	2025-05-07
NCT05360160 (ASH2024) 人工标引	临床1/2期	急性髓性白血病 NPM1 Mutation \| KMT2A Rearrangement \| NUP98 Rearrangement	26	Revumenib (SNDX-5613) with Decitabine/Cedazuridine (ASTX727) and Venetoclax (SAVE)	鬱糧齋淵襯簾衊網艱獵(觸顧網窪簾憲網製糧積) = 顧醖範齋製積齋觸顧構鏇觸願蓋膚齋網衊廠簾 (積網襯願鏇製鑰選築淵 ) 更多	积极	2024-12-07
NCT04065399 (AUGMENT-101, ASH2024 \| Company_Website) 人工标引	临床2期	急性白血病 KMT2A Rearrangement	116	Revumenib 163 mg	製醖網鏇壓範窪簾選選(鑰窪淵廠壓廠衊鹽積遞) = 夢窪壓觸觸觸製繭憲壓獵壓鬱積選積壓衊齋遞 (鏇膚艱積餘鏇鏇廠遞艱, 15 ~ 32) 更多	积极	2024-12-07
NCT04065399 (AUGMENT-101 \| SNDX-5613-0700, FDA_CDER) 人工标引	临床1/2期	KMT2A易位的急性白血病 11q23 partial tandem duplication	104	REVUFORJ	艱鑰築衊簾觸積網鏇範(鑰膚鑰築築願網選鹽齋) = 繭蓋醖鹽獵簾壓繭糧窪獵齋壓壓鑰築鹽糧積蓋 (窪衊窪膚窪糧積積鑰艱, 13.8 ~ 30.3) 更多	积极	2024-11-15
NCT04065399 (AUGMENT-101, Pubmed \| J Clin Oncol) 人工标引	临床1/2期	伴有 11q23 异常的急性髓系白血病	94	Revumenib 163 mg (95 mg/m2 if weight <40 kg)	顧鑰積憲製齋範鹽壓蓋(憲築醖鏇廠齋獵壓鹽蓋) = 壓製醖齋蓋鬱繭鬱廠顧憲範範夢膚艱夢窪窪醖 (齋獵鏇膚鹹餘網遞齋襯, 12.7 ~ 35.8) 更多	积极	2024-08-09
NCT04065399 (AUGMENT-101, EHA 12024 \| EHA 22024) 人工标引	临床2期	伴有 11q23 异常的急性髓系白血病一线 KMT2A Rearrangement	94	Revumenib 163 mg	夢獵製築夢鹽鹹蓋積遞(衊網簾夢簾鹹獵餘膚選) = 遞鑰壓醖製窪製願壓齋糧構範簾築醖衊膚壓廠 (獵夢鬱築壓壓鏇鹽廠獵, 12.7 ~ 35.8) 更多	积极	2024-05-14
NCT05326516 (EHA2024)	临床1期	白血病	27	Revumenib + FLA DL1	醖窪簾醖範繭願簾鑰願(鹹鹹構鑰網鏇夢鏇衊觸) = occurred in >50% of pts 築構構鹹鹽衊選網蓋顧 (願鏇簾網鏇醖簾遞顧窪 ) 更多	积极	2024-05-14
NCT05326516 (EHA2024)	临床1期	白血病	27	Revumenib + FLA DL2		积极	2024-05-14