Withdrawn | Cancer Accelerated Approvals
正文 · 中文译文
已撤回 | 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 临床获益已证实 | 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），这些批准随后被撤回，因此不再获得FDA批准。有关特定产品的最新批准和处方信息，请参阅Drugs@FDA。欲了解更多信息，请访问进行中或临床获益已证实的AA适应症页面。 在FDA发布相应的《联邦公报》通知或更新产品标签之前，已撤回的适应症不会列出。 药物名称加速批准（AA）适应症加速批准日期撤回日期 1 Zepzelca（lurbinectedin）用于治疗在接受过含铂化疗期间或之后出现疾病进展的转移性小细胞肺癌（SCLC）成人患者。6/15/20209/30/2026 Krazati（adagrasib）与西妥昔单抗联合，用于治疗既往接受过含氟尿嘧啶、奥沙利铂和伊立替康方案化疗的KRAS G12C突变局部晚期或转移性结直肠癌成人患者。6/1/20249/1/2026 Tazverik（tazemetostat）用于治疗不适合完全切除的转移性或局部晚期上皮样肉瘤的16岁及以上成人及儿童患者1/23/20206/22/2026 Tazverik（他泽司他）用于治疗成人复发或难治性（R/R）滤泡性淋巴瘤（FL）患者，其肿瘤经FDA批准的检测方法证实为EZH2突变阳性，且既往已接受至少2种全身治疗。用于治疗无满意替代治疗选择的成人R/R FL患者6/18/20206/22/2026 Xpovio（塞利尼索）用于治疗成人复发或难治性弥漫性大B细胞淋巴瘤（DLBCL），非特指型，包括由滤泡性淋巴瘤（FL）转化的DLBCL，且既往已接受至少2线全身治疗。6/22/20204/30/2026 Trodelvy（戈沙妥珠单抗-hziy）用于治疗既往接受过含铂化疗以及程序性死亡受体-1（PD-1）或程序性死亡配体1（PD-L1）抑制剂治疗的成人局部晚期或转移性尿路上皮癌（mUC）患者4/13/202111/22/2024 Exkivity（莫博赛替尼）用于治疗经FDA批准的检测方法证实存在EGFR外显子20插入突变的成人局部晚期或转移性非小细胞肺癌（NSCLC）患者，且其疾病在含铂化疗期间或之后已进展9/15/20217/15/2024 Truseltiq（英菲格拉替尼）用于治疗既往接受过治疗、不可切除的局部晚期或转移性胆管癌成人患者，且经FDA批准的检测方法证实存在成纤维细胞生长因子受体2（FGFR2）基因融合或其他重排5/28/20215/16/2024 Aliqopa（copanlisib）用于治疗已接受至少两种既往全身治疗的复发滤泡性淋巴瘤（FL）成人患者9/14/20173/18/2024 Pepaxto（melphalan flufenamide）与地塞米松联合，用于治疗已接受至少四线既往治疗、且疾病对至少一种蛋白酶体抑制剂、一种免疫调节剂和一种CD-38导向单克隆抗体难治的复发或难治性（R/R）多发性骨髓瘤（MM）成人患者2/26/20212/23/2024 Gavreto（pralsetinib）用于治疗需要全身治疗的12岁及以上晚期或转移性RET突变型甲状腺髓样癌（MTC）成人和儿童患者12/1/20207/20/2023 Imbruvica（ibrutinib）用于已接受至少一种既往治疗的套细胞淋巴瘤（MCL）成人患者11/13/20135/18/2023 Imbruvica（ibrutinib）用于需要全身治疗且已接受至少一种既往抗CD20为基础治疗的边缘区淋巴瘤（MZL）成人患者1/18/20175/18/2023 Blenrep（belantamab mafodotin-blmf）用于已接受至少四种既往治疗（包括抗CD38单克隆抗体、蛋白酶体抑制剂和免疫调节剂）的复发或难治性（R/R）多发性骨髓瘤（MM）成人患者8/5/20202/6/2023 Tecentriq（阿替利珠单抗）适用于不适合含顺铂化疗、且经FDA批准检测证实肿瘤表达PD-L1的局部晚期或转移性尿路上皮癌（mUC）患者，或无论PD-L1状态如何均不适合任何含铂化疗的患者4/17/201712/2/2022 Ukoniq（umbralisib）适用于既往接受过至少一种抗CD20方案治疗的复发或难治性边缘区淋巴瘤（MZL）成人患者 2/5/20215/31/2022 Ukoniq（umbralisib）适用于既往接受过至少三线系统性治疗的复发或难治性滤泡性淋巴瘤（FL）成人患者2/5/20215/31/2022 Marqibo（硫酸长春新碱脂质体）适用于费城（PH）染色体阴性（-）急性淋巴细胞白血病（ALL）成人患者，处于第二次或以上复发，或疾病在2线或以上抗白血病治疗后进展8/9/20125/2/2022 Farydak（帕比司他）与硼替佐米（BTZ）和地塞米松（DEX）联合用于治疗既往接受过至少2种方案（包括BTZ和一种免疫调节剂）的多发性骨髓瘤（MM）患者。2/23/20153/24/2022 Zydelig（艾代拉利司）用于治疗既往接受过至少2种系统性治疗的复发滤泡性B细胞非霍奇金淋巴瘤（FL）患者，以及既往接受过至少2种系统性治疗的复发小淋巴细胞淋巴瘤（SLL）患者 7/23/20142/18/2022 Keytruda（帕博利珠单抗）用于经FDA批准的检测确定肿瘤表达PD-L1［CPS≥1］的复发性或局部晚期或转移性胃或胃食管结合部（GEJ）腺癌患者，且在接受包括氟嘧啶和铂类化疗在内的两种或以上既往治疗方案后（如适用，还包括HER2/NEU靶向治疗）出现疾病进展 9/22/2017 2/4/2022 Copiktra（度维利塞）用于治疗至少接受过2种既往系统性治疗后复发或难治性滤泡性淋巴瘤（FL）的成人患者 9/24/2018 12/17/2021 Keytruda（帕博利珠单抗）用于铂类化疗期间或之后以及至少接受过另一种既往治疗方案后出现疾病进展的转移性小细胞肺癌（SCLC） 6/17/2019 3/30/2021 Tecentriq（阿替利珠单抗）与白蛋白结合型紫杉醇联合用于不可切除的局部晚期或转移性三阴性乳腺癌，其肿瘤经FDA批准的检测确定表达PD-L1（任何强度的PD-L1染色肿瘤浸润免疫细胞覆盖≥1%的肿瘤区域） 3/8/2019 10/6/2021 Opdivo（纳武利尤单抗）用于铂类化疗后以及至少接受过另一种治疗方案后出现进展的转移性小细胞肺癌（SCLC） 8/16/2018 12/29/2020 Opdivo（纳武利尤单抗）用于既往接受过索拉非尼治疗的肝细胞癌 9/22/2017 7/23/2021 Imfinzi（度伐利尤单抗）用于在含铂化疗期间或之后，或在含铂化疗新辅助或辅助治疗后12个月内出现进展的局部晚期或转移性尿路上皮癌 5/1/2017 2/19/2021 Lartruvo（olaratumab）与多柔比星联合用于患有软组织肉瘤的成人，其组织学亚型适合含蒽环类方案且不适合以放疗或手术治愈10/19/20162/25/2020 Tecentriq（atezolizumab）用于局部晚期或转移性尿路上皮癌，患者在含铂化疗期间或之后疾病进展，或在含铂化疗新辅助或辅助治疗后12个月内疾病进展5/18/20164/13/2021 Istodax（romidepsin）用于已接受至少一种既往治疗的外周T细胞淋巴瘤患者6/16/20117/30/2021 Oforta（磷酸氟达拉滨）用于对至少一种含标准烷化剂方案治疗无应答或在该治疗期间或之后疾病进展的成人B细胞慢性淋巴细胞白血病（CLL）12/18/200812/31/2011 Avastin（贝伐珠单抗）与紫杉醇联合用于未接受过化疗的转移性HER2阴性乳腺癌患者2/22/200811/18/2011 Bexxar（托西莫单抗和碘I 131托西莫单抗）用于未接受过利妥昔单抗的复发性或难治性低级别滤泡性或转化型CD20+非霍奇金淋巴瘤（NHL）患者12/22/200410/23/2013 Iressa（吉非替尼）作为单药治疗用于含铂方案和多西他赛化疗失败后的局部晚期或转移性非小细胞肺癌（NSCLC）5/5/20034/25/2012 Mylotarg（吉妥珠单抗奥唑米星）用于年龄60岁及以上、不适合细胞毒性化疗的首次复发CD33+急性髓系白血病（AML）患者5/17/200011/28/2011 Celebrex（塞来昔布）用于减少家族性腺瘤性息肉病患者的腺瘤性结直肠息肉数量，作为常规治疗的辅助用药1999年12月23日2012年6月8日 1撤回日期指《联邦公报》发布的生效日期或产品标签更新日期，以两者中较早者为准。 内容截至日期： 2026年10月5日 受监管产品 药品
正文 · 英文原文
Withdrawn | 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 been subsequently withdrawn, and are therefore, no longer FDA-approved. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. Visit the ongoing or verified AA indication pages for more information. Withdrawn indications are not listed until FDA publishes a Federal Register notice to that effect or updates product labeling. Drug NameAccelerated Approval (AA) IndicationAccelerated Approval DateWithdrawal Date 1 Zepzelca (lurbinectedin)Treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after prior platinum-based chemotherapy.6/15/20209/30/2026 Krazati (adagrasib)In combination with cetuximab for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.6/1/20249/1/2026 Tazverik (tazemetostat)Treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection1/23/20206/22/2026 Tazverik (tazemetostat)Treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. Treatment of adult patients with R/R FL who have no satisfactory alternative treatment options6/18/20206/22/2026 Xpovio (selinexor)Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma (FL), after at least 2 lines of systemic therapy.6/22/20204/30/2026 Trodelvy (sacituzumab govitecan-hziy)Treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor 4/13/202111/22/2024 Exkivity (mobocertinib)Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy9/15/20217/15/2024 Truseltiq (infigratinib)Treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangement as detected by an FDA approved test5/28/20215/16/2024 Aliqopa (copanlisib)Treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies9/14/20173/18/2024 Pepaxto (melphalan flufenamide)In combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody2/26/20212/23/2024 Gavreto (pralsetinib)Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy12/1/20207/20/2023 Imbruvica (ibrutinib)Adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy11/13/20135/18/2023 Imbruvica (ibrutinib)Adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy1/18/20175/18/2023 Blenrep (belantamab mafodotin-blmf)Adults patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent8/5/20202/6/2023 Tecentriq (atezolizumab)Patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 as determined by an FDA approved test or who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status4/17/201712/2/2022 Ukoniq (umbralisib)Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20- based regimen 2/5/20215/31/2022 Ukoniq (umbralisib)Adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy2/5/20215/31/2022 Marqibo (vincristine sulfate liposomal)Adults with Philadelphia (PH) chromosome negative (-) ALL in second relapse or greater relapsed or whose disease has progressed following 2 or greater treatment lines of anti-leukemia therapies8/9/20125/2/2022 Farydak (panobinostat)In combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior regimens, including BTZ and an immunomodulatory agent.2/23/20153/24/2022 Zydelig (idelalisib)For the treatment of relapsed follicular B-cell Non-Hodgkin Lymphoma (FL) in patients who have received at least 2 prior systemic therapies and relapsed small lymphocytic lymphoma (SLL) in patients who have received at least 2 prior systemic therapies 7/23/20142/18/2022 Keytruda (pembrolizumab)For patients with recurrent or locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 [CPS ≥1] as determined by an FDA-approved test, with disease progression on/after two or more prior lines of therapy including fluoropyrimidine and platinum containing chemotherapy and if appropriate, HER2/NEU targeted therapy9/22/20172/4/2022 Copiktra (duvelisib)Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies9/24/201812/17/2021 Keytruda (pembrolizumab)Metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy6/17/20193/30/2021 Tecentriq (atezolizumab)In combination with paclitaxel protein-bound for unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering = 1% of the tumor area), as determined by an FDA-approved test.3/8/201910/6/2021 Opdivo (nivolumab)Metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapy8/16/201812/29/2020 Opdivo (nivolumab)Hepatocellular carcinoma previously treated with sorafenib9/22/20177/23/2021 Imfinzi (durvalumab)Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy5/1/20172/19/2021 Lartruvo (olaratumab)In combination with doxorubicin for adults with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery10/19/20162/25/2020 Tecentriq (atezolizumab)Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy5/18/20164/13/2021 Istodax (romidepsin)Peripheral T-cell lymphoma in patients who have received at least one prior therapy6/16/20117/30/2021 Oforta (fludarabine phosphate)For adults with B-cell CLL that has not responded to or progressed during or after treatment with at least one standard alkylating agent containing regimen12/18/200812/31/2011 Avastin (bevacizumab)In combination with paclitaxel for patients who have not received chemotherapy for metastatic HER2 negative breast cancer2/22/200811/18/2011 Bexxar (tositumomab and iodine i 131 tositumomab)For patients with relapsed or refractory low-grade follicular or transformed CD20+ NHL who have not received rituximab12/22/200410/23/2013 Iressa (gefitinib)As monotherapy for locally advanced or metastatic NSCLC after failure of platinum-based and docetaxel chemotherapy5/5/20034/25/2012 Mylotarg (gemtuzumab ozogamicin)For patients with CD33+ AML in first relapse 60 years of age or older and not candidates for cytotoxic chemotherapy5/17/200011/28/2011 Celebrex (celecoxib)To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis patients, as an adjunct to usual care12/23/19996/8/2012 1Withdrawal date indicates either the effective date published by the Federal Register or the date the product label was updated, whichever date came first. Content current as of: 10/05/2026 Regulated Product(s) Drugs
摘要 待译
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved.