Ongoing | Cancer Accelerated Approvals
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进行中 | 癌症加速批准 癌症批准 肿瘤（癌症）/血液系统恶性肿瘤批准通知 进行中 | 癌症加速批准 已证实临床获益 | 癌症加速批准 已撤回 | 癌症加速批准 其他 | 癌症加速批准 本列表包含针对恶性血液病和肿瘤适应症的加速批准（AA），这些适应症具有正在进行的临床试验的上市后要求，以验证临床获益。请参阅 Drugs@FDA 获取特定产品的最新批准和处方信息。访问已证实和已撤回的 AA 适应症页面以获取更多信息，以及上市后要求和承诺页面以了解特定要求的状态。 在 FDA 更新产品标签或发布关于状态变更的联邦公报通知之前，适应症可能会保留在本页面上。 药物名称 加速批准（AA）适应症 AA 日期 AA 上市后要求 原始预计完成时间 1 Rybrevant Faspro（amivantamab 和透明质酸酶-lpuj）用于治疗在含铂化疗和抗 PD-(L)1 抗体治疗后疾病进展的复发或转移性头颈部鳞状细胞癌（HNSCC）成人患者 2026年11月5日 5095-1：完成正在进行的多中心、随机临床试验 Study OrigAMI-5，旨在验证和描述 amivantamab 和透明质酸酶-lpuj 在 HPV 无关的复发或转移性头颈部鳞状细胞癌（R/M HNSCC）成人患者中的临床获益。2029年5月31日 Jemperli（dostarlimab-gxly）用于治疗经FDA批准的实体瘤检测确定为微卫星不稳定高（MSI-H）或dMMR的II/III期局部晚期直肠癌（LARC）成人患者10/19/20265084-1：完成正在进行的临床试验AZUR-1（NCT05723562），题为“一项在未经治疗的II/III期dMMR/MSI-H局部晚期直肠癌受试者中评估dostarlimab单药治疗的2期、单臂、开放标签研究”，以验证并描述dostarlimab对dMMR/MSI-H未经治疗II/III期局部晚期直肠癌患者的临床获益。描述完全缓解的持续时间（cCR12、cCR24和cCR36）、3年时器官保留率、3年时复发或发生转移性疾病的比例，以及5年生存随访。7/31/2030 Hyrnuo（sevabertinib）用于治疗经FDA批准的检测发现肿瘤具有HER2（ERBB2）酪氨酸激酶结构域（TKD）激活突变的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）成人患者9/9/20264933-1：完成正在进行的多中心、随机临床试验Study SOHO-02，旨在验证并描述sevabertinib在肿瘤具有HER2（ERBB2）酪氨酸激酶结构域激活突变且未接受过晚期疾病既往治疗的局部晚期或转移性非鳞状NSCLC成人患者中的临床获益。10/31/2029 Etcamah（camizestrant）联合CDK4/6抑制剂（阿贝西利、哌柏西利或瑞波西利），用于治疗在接受芳香化酶抑制剂和CDK4/6抑制剂治疗期间经FDA授权检测发现ESR1突变的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性局部晚期或转移性乳腺癌成人患者9/4/20265047-1：在接受一线芳香化酶抑制剂和CDK4/6抑制剂治疗的HR+/HER2-转移性乳腺癌（MBC）患者中完成一项随机试验，比较在检测到ESR1突变时（影像学进展前）将治疗更换为camizestrant并继续CDK4/6抑制剂与在影像学疾病进展时将治疗更换为camizestrant联合/不联合继续CDK4/6抑制剂，以验证camizestrant的临床获益，并提交预设的策略失败时间（TSF）和总生存期（OS）结果。 5047-2：完成正在进行的临床试验SERENA-6，题为“一项评估在HR+/HER2-转移性乳腺癌患者中，于一线芳香化酶抑制剂+CDK4/6抑制剂治疗期间可检测到ESR1突变且无疾病进展时，换用camizestrant+CDK4/6抑制剂对比继续芳香化酶抑制剂（来曲唑或阿那曲唑）+CDK4/6抑制剂的3期、双盲、随机研究——一项ctDNA指导的早期换药研究”，以提供最终OS结果，验证camizestrant的临床获益。 9/30/2028 Zenbexus（iberdomide）与达雷妥尤单抗及透明质酸酶-fihj和地塞米松联合，用于治疗已接受至少1线既往治疗（包括蛋白酶体抑制剂和免疫调节剂）的成年多发性骨髓瘤患者8/13/20265041-1：完成一项iberdomide联合达雷妥尤单抗及透明质酸酶-fihj和地塞米松与达雷妥尤单抗及透明质酸酶-fihj和地塞米松及硼替佐米相比在复发或难治性多发性骨髓瘤患者中的随机对照试验。主要终点应为无进展生存期，次要终点应包括总生存期和总缓解率。5/31/2028 Tudriqev（vusolimogene oderparepvec-wtpg）与纳武利尤单抗联合，用于治疗在接受以程序性死亡受体-1（PD-1）阻断抗体为基础的方案后出现疾病进展的不可切除晚期皮肤黑色素瘤成年患者8/6/20261：Replimune， Inc.须完成IGNYTE-3（RP1-104）试验（NCT06264180），这是一项正在进行的3期多中心、多区域、随机、对照、开放标签确证性试验，旨在评估vusolimogene oderparepvec联合纳武利尤单抗与研究者选择治疗相比在抗PD-1和抗CTLA-4联合或序贯治疗后确认疾病进展的不可切除晚期皮肤黑色素瘤患者中的安全性和有效性。总生存期为主要终点。约400例患者将按1：1比例随机分配至两个治疗组。3/31/2031 Beqalzi（sonrotoclax）用于治疗至少接受过两线系统性治疗（包括布鲁顿酪氨酸激酶（BTK）抑制剂）后复发或难治性套细胞淋巴瘤（MCL）的成年患者。2026年5月13日4994-1：完成一项随机临床试验，旨在验证和描述sonrotoclax在MCL患者中的临床获益。该试验应将复发或难治性MCL患者随机分配至接受sonrotoclax联合泽布替尼或安慰剂联合泽布替尼治疗。主要终点应为由独立审查委员会评估的无进展生存期（PFS），关键次要终点包括总生存期（OS）。该试验应纳入足够的种族和族裔人群代表性，以反映美国MCL患者人群，并允许在这些患者人群中解释结果。2030年9月30日 Hernexeos（zongertinib）用于治疗经FDA授权检测发现肿瘤具有HER2（ERBB2）酪氨酸激酶结构域激活突变的不可切除或转移性非鳞状非小细胞肺癌（NSCLC）成年患者。2026年2月26日4881-1：完成正在进行的多中心随机临床试验Beamion LUNG-2研究，旨在验证和描述zongertinib在晚期、不可切除或转移性非鳞状非小细胞肺癌且肿瘤具有HER2（ERBB2）酪氨酸激酶结构域激活突变的成年患者中的临床获益。2029年11月30日 Hyrnuo（sevabertinib）用于治疗经FDA批准的检测方法检出肿瘤具有HER2（ERBB2）酪氨酸激酶结构域（TKD）激活突变的、且已接受过一种既往全身治疗的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）成人患者11/19/20254933-1：完成正在进行的多中心、随机临床试验SOHO-02研究，旨在验证并描述sevabertinib在肿瘤具有HER2（ERBB2）酪氨酸激酶结构域激活突变且未接受过晚期疾病既往治疗的局部晚期或转移性非鳞状NSCLC成人患者中的临床获益。10/31/2029 Hernexeos（zongertinib）用于治疗经FDA批准的检测方法检出肿瘤具有HER2（ERBB2）酪氨酸激酶结构域激活突变的、且已接受过既往全身治疗的不可切除或转移性非鳞状非小细胞肺癌（NSCLC）成人患者8/8/20254881-1：完成正在进行的多中心、随机临床试验Beamion LUNG-2研究，旨在验证并描述zongertinib在肿瘤具有HER2（ERBB2）酪氨酸激酶结构域激活突变的晚期、不可切除或转移性非鳞状非小细胞肺癌成人患者中的临床获益。11/30/2029 Modeyso（dordaviprone）用于治疗1岁及以上成人和儿童患者中携带H3 K27M突变、既往治疗后疾病进展的弥漫性中线胶质瘤。2025年8月6日4861-1：在H3 K27M突变型弥漫性中线胶质瘤患者中完成一项多区域、随机临床试验，旨在通过评估总生存期（OS）作为主要终点，验证并描述dordaviprone的临床获益。 4861-2：在H3 K27M突变型弥漫性中线胶质瘤儿童患者（<17岁）中开展一项临床试验，纳入足够数量的弥漫性内生性桥脑胶质瘤（DIPG）患者，旨在验证并描述dordaviprone在儿童人群中的临床获益。所评估的终点应包括总缓解率（ORR）、缓解持续时间（DOR）和总生存期（OS）。2031年7月31日 Zegfrovy（sunvozertinib）用于治疗经FDA批准的检测方法检出表皮生长因子受体（EGFR）外显子20插入突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者 2025年7月2日 4867-1 开展一项多中心、随机临床试验，旨在验证并描述sunvozertinib在肿瘤携带EGFR外显子20插入突变的局部晚期、不可切除或转移性非小细胞肺癌患者中的临床获益。最终分析应包括最终的无进展生存期和总生存期结果。该数据可自正在进行的临床试验获得，试验名称为DZ2022E0005（WU-KONG28），“一项DZD9008对比含铂双药化疗作为携带表皮生长因子受体外显子20插入突变的局部晚期或转移性非小细胞肺癌患者一线治疗的3期、开放标签、随机、多中心研究。”2026年7月31日 Lynozyfic（linvoseltamab-gcpt）用于治疗既往接受过至少四线治疗（包括蛋白酶体抑制剂、免疫调节剂和抗CD38单克隆抗体）的复发或难治性多发性骨髓瘤成人患者。2025年7月2日4848-1：在复发或难治性多发性骨髓瘤患者中完成一项随机临床试验。患者应被随机分配接受linvoseltamab治疗或复发或难治性多发性骨髓瘤的标准治疗。主要终点应为无进展生存期，关键次要终点应包括总缓解率和总生存期。该试验应纳入具有充分代表性的研究人群，以使结果可推广至美国多发性骨髓瘤患者人群。2027年6月30日 Datroway（datopotamab deruxtecan-dlnk）用于治疗既往接受过EGFR靶向治疗和含铂化疗的局部晚期或转移性表皮生长因子受体（EGFR）突变非小细胞肺癌（NSCLC）成人患者。2025年6月23日4860-1：开展一项多中心、随机临床试验TROPION-LUNG15，旨在验证并描述datopotamab deruxtecan在奥希替尼治疗后疾病进展的EGFR突变非小细胞肺癌患者中的临床获益。2029年11月30日 Emrelis（telisotuzumab vedotin-tllv）用于治疗经FDA批准检测确定为c-Met蛋白高表达[≥50%的肿瘤细胞呈强（3+）染色]、且既往接受过一种系统性治疗的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）成人患者。5/14/20254844-1：完成正在进行的随机试验Study M18-868，旨在验证并描述telisotuzumab vedotin在既往接受过治疗、c-Met高表达、EGFR野生型、局部晚期/转移性非鳞状非小细胞肺癌患者中的临床获益。6/30/2029 Avmapki Fakzynja Co-Pack（avutometinib胶囊；defactinib片剂）用于治疗既往接受过系统性治疗的KRAS突变复发性低级别浆液性卵巢癌（LGSOC）成人患者5/8/20254835-1：完成正在进行的题为“RAMP 301：一项在复发性低级别浆液性卵巢癌（LGSOC）患者中比较Avutometinib联合Defactinib治疗与研究者选择治疗的3期、随机、开放标签研究”的试验，并提供无进展生存期和最终总生存期分析，旨在描述并验证avutometinib与defactinib联合治疗在复发性、KRAS突变低级别浆液性卵巢癌成人患者中的临床获益。纳入所有患者的中心KRAS检测结果。6/30/2028 Breyanzi（lisocabtagene maraleucel）适用于复发/难治性慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）的成人患者，且患者已接受过至少两线既往治疗，包括布鲁顿酪氨酸激酶（BTK）抑制剂和B细胞淋巴瘤-2（BCL-2）抑制剂 2024年3月21日 1- 开展一项lisocabtagene maraleucel单臂研究，纳入已接受至少2线既往治疗（包括既往布鲁顿酪氨酸激酶（BTK）抑制剂和B细胞淋巴瘤2（BCL-2）抑制剂）的复发或难治性慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）患者，以评估总缓解率和缓解持久性。该研究必须总共纳入50例接受治疗的患者，持久缓解应基于首次客观疾病缓解后至少15个月的随访。2027年5月31日 Bizengri（zenocutuzumab-zbco）用于治疗携带神经调节蛋白1（NRG1）基因融合、且在既往全身治疗后出现疾病进展的晚期不可切除或转移性胰腺腺癌成人患者。12/4/20244727-2：完成一项临床试验，旨在验证并描述zenocutuzumab 750 mg每两周静脉给药在至少50例可评估的携带神经调节蛋白1（NRG1）基因融合、且在既往全身治疗后出现疾病进展（或不适合标准治疗）的晚期不可切除或转移性胰腺腺癌成人患者中的临床获益。为描述缓解率和缓解持续时间，患者将自缓解起始随访至少12个月。8/31/2026 Bizengri（zenocutuzumab-zbco）用于治疗携带神经调节蛋白1（NRG1）基因融合、且在既往全身治疗后出现疾病进展的晚期不可切除或转移性非小细胞肺癌（NSCLC）成人患者。12/4/20244727-1：完成一项临床试验，旨在验证并描述zenocutuzumab 750 mg每两周静脉给药在至少100例可评估的携带神经调节蛋白1（NRG1）基因融合、且在既往全身治疗后出现疾病进展的晚期不可切除或转移性NSCLC成人患者中的临床获益。为描述缓解率和缓解持续时间，患者将自缓解起始随访至少12个月。8/31/2026 Ziihera（zanidatamab-hrii）用于治疗既往接受过治疗、不可切除或转移性HER2阳性（IHC 3+）胆道癌（BTC）成人患者，经FDA批准的检测方法确认11/20/20244732-1：完成正在进行的随机临床试验研究JZP598-302，题为“zanidatamab联合标准治疗对比单独标准治疗用于晚期HER2阳性胆道癌疗效与安全性的开放标签随机试验”，旨在验证和描述zanidatamab对HER2阳性（IHC3+）、不可切除或转移性胆道癌患者的临床获益。该试验应在HER2阳性（IHC3+）、不可切除或转移性胆道癌患者中比较zanidatamab联合标准治疗与标准治疗。9/30/2029 Scemblix（asciminib）用于治疗新诊断的费城染色体阳性慢性髓性白血病（Ph+ CML）慢性期（CP）成人患者。10/29/20244724-1：完成临床研究CABL001J12301（ASC4FIRST），一项在Newly Diagnosed费城染色体阳性慢性髓性白血病慢性期患者中比较口服asciminib与研究者选择TKI的3期、多中心、开放标签、随机研究，旨在描述和确认asciminib的临床获益，包括对所有患者至少60个月的随访。6/30/2028 Tecelra（afamitresgene autoleucel）用于治疗既往接受过化疗、HLA-A*02:01P、-A*02:02P、-A*02:03P或-A*02:06P阳性且经FDA批准或许可的伴随诊断器械确定肿瘤表达MAGE-A4抗原的不可切除或转移性滑膜肉瘤成人患者。2024年8月2日1：提交最终临床研究报告，包括ADP-0044-002队列2和队列3的数据集，以通过更精确地估计独立评审评估的总体缓解率和成熟缓解持续时间，验证并描述afamitresgene autoleucel在既往接受过治疗的不可切除或转移性滑膜肉瘤成人患者中的临床获益
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Ongoing | Cancer Accelerated Approvals Cancer Approvals Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. Visit the verified and withdrawn AA indication pages for more information and the Postmarket Requirements and Commitments page for the status of specific requirements. Indications may remain on this page until FDA updates product labeling or publishes a Federal Register notice regarding a change in status. Drug NameAccelerated Approval (AA) IndicationAA DateAA Post-Marketing RequirementOriginal Projected Completion 1 Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)Treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody11/5/20265095-1: Complete the ongoing multicenter, randomized clinical trial, Study OrigAMI-5, intended to verify and describe the clinical benefit of amivantamab and hyaluronidase-lpuj in adult patients with HPV-unrelated recurrent or metastatic head and neck squamous cell cancer (R/M HNSCC).5/31/2029 Jemperli (dostarlimab-gxly)Treatment of adult patients with Stage II/III, locally advanced rectal cancer (LARC) that is microsatellite instability-high (MSI-H) or dMMR, as determined by anFDA-authorized test for solid tumor10/19/20265084-1: Complete the ongoing clinical trial, AZUR-1 (NCT05723562), entitled, “A Phase 2, Single-Arm, Open-Label Study with Dostarlimab Monotherapy in Participants with Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer”, to verify and describe the clinical benefit of dostarlimab for patients with dMMR/MSI-H untreated Stage II/III locally advanced rectal cancer. Characterize the duration of the complete response (cCR12, cCR24, and cCR36), organ preservation rate at 3 years, rate of relapse or development of metastatic disease at 3 years, and 5-year follow-up for survival.7/31/2030 Hyrnuo (sevabertinib)Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test9/9/20264933-1: Complete the ongoing multicenter, randomized clinical trial, Study SOHO-02, intended to verify and describe the clinical benefit of sevabertinib in adult patients with locally advanced or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations and who have not received prior therapy for advanced disease.10/31/2029 Etcamah (camizestrant)In combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test9/4/20265047-1: Complete a randomized trial in patients with HR+/HER2- MBC receiving first-line treatment with an aromatase inhibitor and CDK4/6 inhibitor which compares changing therapy to camizestrant with continued CDK4/6 inhibitor at ESR1m detection (prior to radiographic progression) to changing therapy to camizestrant +/- continued CDK4/6 inhibitor at radiographic disease progression for verification of the clinical benefit with camizestrant and submit the prespecified time to strategy failure (TSF) and overall survival (OS) results. 5047-2: Complete the ongoing clinical trial SERENA-6, titled “A Phase 3, Doubleblind, Randomized Study to Assess Switching to Camizestrant + CDK4/6 Inhibitor versus Continuing Aromatase Inhibitor (Letrozole or Anastrozole) + CDK4/6 Inhibitor in HR+/HER2- MBC Patients with Detectable ESR1 Mutation Without Disease Progression During 1L Treatment with Aromatase Inhibitor + CDK4/6 Inhibitor – A ctDNA Guided Early Switch Study” to provide the final OS results for verification of clinical benefit of camizestrant. 9/30/2028 Zenbexus (iberdomide)In combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent8/13/20265041-1: Complete a randomized controlled trial of iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone compared to daratumumab and hyaluronidase-fihj and dexamethasone and bortezomib in patients with relapsed or refractory multiple myeloma. The primary endpoint should be progression-free survival and secondary endpoints should include overall survival and overall response rate.5/31/2028 Tudriqev (vusolimogene oderparepvec-wtpg)In combination with nivolumab for treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen8/6/20261: Replimune, Inc. is required to complete the IGNYTE-3 (RP1-104) trial (NCT06264180), an ongoing Phase 3 multicenter, multiregional, randomized, controlled, open-label confirmatory trial to evaluate the safety and efficacy of vusolimogene oderparepvec in combination with nivolumab compared with treatment of physician’s choice in patients with unresectable advanced cutaneous melanoma who have confirmed disease progression on an anti-PD-1 and an anti-CTLA-4 either in combination or in sequence. Overall survival is the primary endpoint. Approximately 400 patients will be randomized at 1:1 ratio to the two treatment arms.3/31/2031 Beqalzi (sonrotoclax)Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.5/13/20264994-1: Complete a randomized clinical trial intended to verify and describe the clinical benefit of sonrotoclax in patients with MCL. The trial should randomize patients with relapsed or refractory MCL to receive sonrotoclax in combination with zanubrutinib or placebo in combination with zanubrutinib. The primary endpoint should be PFS as assessed by an independent review committee, with key secondary endpoints that include OS. The trial should include sufficient representation of racial and ethnic populations to reflect the U.S. patient population with MCL and allow for interpretation of the results in these patient populations.9/30/2030 Hernexeos (zongertinib)Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test2/26/20264881-1: Complete the ongoing multicenter, randomized clinical trial, Study Beamion LUNG-2, intended to verify and describe the clinical benefit of zongertinib in adult patients with advanced, unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations.11/30/2029 Hyrnuo (sevabertinib)Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy11/19/20254933-1: Complete the ongoing multicenter, randomized clinical trial, Study SOHO-02, intended to verify and describe the clinical benefit of sevabertinib in adult patients with locally advanced or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations and who have not received prior therapy for advanced disease.10/31/2029 Hernexeos (zongertinib)Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA approved test, and who have received prior systemic therapy8/8/20254881-1: Complete the ongoing multicenter, randomized clinical trial, Study Beamion LUNG-2, intended to verify and describe the clinical benefit of zongertinib in adult patients with advanced, unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations.11/30/2029 Modeyso (dordaviprone)Treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.8/6/20254861-1: Complete a multiregional, randomized clinical trial in patients with H3 K27M-mutant diffuse midline glioma, intended to verify and describe the clinical benefit of dordaviprone through assessment of overall survival (OS) as a primary endpoint. 4861-2: Conduct a clinical trial in pediatric patients (<17 years of age) with H3 K27M-mutant diffuse midline glioma, inclusive of a sufficient number of patients with Diffuse Intrinsic Pontine Glioma (DIPG), intended to verify and describe the clinical benefit of dordaviprone in the pediatric population. Endpoints evaluated should include overall response rate (ORR), duration of response (DOR), and overall survival (OS).7/31/2031 Zegfrovy (sunvozertinib)Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test7/2/20254867-1 Conduct a multicenter, randomized clinical trial intended to verify and describe the clinical benefit of sunvozertinib in patients with locally advanced, unresectable or metastatic non-small cell lung cancer whose tumors have EGFR exon 20 insertion mutations. The final analysis should include the final progression-free survival and overall survival results. This data may be obtained from the ongoing clinical trial, entitled, DZ2022E0005 (WU-KONG28), “A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation.”7/31/2026 Lynozyfic (linvoseltamab-gcpt)Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.7/2/20254848-1: Complete a randomized clinical trial in patients with relapsed or refractory multiple myeloma. Patients should be randomized to receive linvoseltamab compared to standard therapy for relapsed or refractory multiple myeloma. The primary endpoint should be progression-free survival and key secondary endpoints should include overall response rate and overall survival. The trial should enroll a sufficiently representative study population to allow for generalizability of the result to the U.S. patient population with multiple myeloma.6/30/2027 Datroway (datopotamab deruxtecan-dlnk)Treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.6/23/20254860-1: Conduct a multicenter, randomized clinical trial, TROPION-LUNG15, intended to verify and describe the clinical benefit of datopotamab deruxtecan in patients with EGFR-mutated non-small cell lung cancer who have had disease progression after osimertinib.11/30/2029 Emrelis (telisotuzumab vedotin-tllv)Treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.5/14/20254844-1: Complete the ongoing randomized trial, Study M18-868, intended to verify and describe the clinical benefit of telisotuzumab vedotin in patients with previously treated c-Met overexpressing, EGFR wildtype, locally advanced/metastatic non-squamous non-small cell lung cancer.6/30/2029 Avmapki Fakzynja Co-Pack (avutometinib capsules; defactinib tablets)Treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy5/8/20254835-1: Complete the ongoing trial titled, “RAMP 301: A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)”, and provide the progression-free survival and the final overall survival analyses, intended to describe and verify the clinical benefit of avutometinib and defactinib in combination in adult patients with recurrent, KRAS-mutated low grade serous ovarian cancer. Include central KRAS testing results for all patients.6/30/2028 Breyanzi (lisocabtagene maraleucel)Adult patients with relapsed/ refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have received at least two prior lines of therapy including a Bruton’s tyrosine kinase (BTK) inhibitor and a B-cell lymphoma-2 (BCL-2) inhibitor 3/21/20241- Conduct a single arm study of lisocabtagene maraleucel in 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 prior Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor, to evaluate overall response rate and durability. The study must include a total of 50 treated patients and durable response should be based on a minimum follow-up of 15 months after first objective disease response. 5/31/2027 Bizengri (zenocutuzumab-zbco)Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.12/4/20244727-2: Complete a clinical trial intended to verify and describe the clinical benefit of zenocutuzumab 750 mg intravenously every two weeks in at least 50 evaluable adult patients with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy (or who are not eligible for standard of care therapy). To characterize response rate and duration, patients will be followed for at least 12 months from the onset of response.8/31/2026 Bizengri (zenocutuzumab-zbco)Treatment of adults with advanced unresectable or metastatic nonsmall cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.12/4/20244727-1: Complete a clinical trial intended to verify and describe the clinical benefit of zenocutuzumab 750 mg intravenously every two weeks in at least 100 evaluable adult patients with advanced unresectable or metastatic NSCLC harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. To characterize response rate and duration, patients will be followed for at least 12 months from the onset of response.8/31/2026 Ziihera (zanidatamab-hrii)Treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test11/20/20244732-1: Complete the ongoing randomized clinical trial, Study JZP598-302, entitled, “An Open-Label Randomized Trial of the Efficacy and Safety of Zanidatamab with Standard-of-Care Therapy Against Standard-of-Care Therapy Alone for Advanced HER2-Positive Biliary Tract Cancer”, intended to verify and describe the clinical benefit of zanidatamab for patients with HER2-positive (IHC3+), unresectable or metastatic biliary tract cancer. The trial should compare zanidatamab in combination with the standard of care in patients with HER2-positive (IHC3+), unresectable or metastatic biliary tract cancer.9/30/2029 Scemblix (asciminib)Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).10/29/20244724-1:Complete clinical study CABL001J12301 (ASC4FIRST), A Phase 3, Multi-center, Open-label, Randomized Study of Oral Asciminib versus Investigator Selected TKI in Patients with Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase, intended to describe and confirm the clinical benefit of asciminib to include at least 60 months follow-up of all patients.6/30/2028 Tecelra (afamitresgene autoleucel)Treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.8/2/20241: Submit the Final Clinical Study Report, including datasets from ADP-0044-002 Cohorts 2 and 3, to verify and describe the clinical benefit of afamitresgene autoleucel, through more precise estimation of the overall response rate and mature response duration per independent review assessment, in adults with unresectable or metastatic synovial sarcoma who have received
摘要 待译
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.