Other | Cancer Accelerated Approvals
正文 · 中文译文
其他 | 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 已验证临床获益 | 癌症加速批准 已撤回 | 癌症加速批准 其他 | 癌症加速批准 本列表包括针对恶性血液肿瘤和肿瘤适应证的加速批准（AA），这些批准涉及支持治疗产品以及给药方案或剂型变更。有关特定产品的最新批准和处方信息，请参阅 Drugs@FDA。 药物名称 加速批准适应证 加速批准日期 当前状态 1 Lunsumio Velo（mosunetuzumab-axgb）剂型：用于治疗接受过两线或以上系统性治疗后复发或难治性滤泡性淋巴瘤的成人患者。2025年12月19日 进行中 Keytruda Qlex（pembrolizumab and berahyaluronidase alfa-pmph）剂型：用于治疗12岁及以上成人和儿童患者中不可切除或转移性肿瘤突变负荷高（TMB-H）[≥10个突变/兆碱基（mut/Mb）]的实体瘤，该状态由FDA批准的检测确定，且既往治疗后出现疾病进展，并且没有满意的替代治疗选择。2025年9月19日 已获传统批准（2026年10月16日） Brukinsa（zanubrutinib）剂型：用于治疗既往接受过至少一种治疗的套细胞淋巴瘤（MCL）成人患者。2025年6月10日 进行中 Brukinsa（泽布替尼）制剂：用于治疗已接受至少一种抗CD20方案的复发或难治性边缘区淋巴瘤（MZL）成人患者。2025年6月10日进行中 Brukinsa（泽布替尼）制剂：用于治疗接受过两线或以上系统性治疗后复发或难治性滤泡性淋巴瘤（FL）成人患者，与奥妥珠单抗联合使用。2025年6月10日进行中 Vitrakvi（拉罗替尼）制剂：用于治疗成人和儿童实体瘤患者，这些患者具有神经营养受体酪氨酸激酶（NTRK）基因融合且无已知获得性耐药突变；为转移性或手术切除可能导致严重并发症；且无满意替代治疗或治疗后进展。2018年11月26日已获传统批准（2025年4月9日） Vijoice（阿培利司）制剂：用于治疗2岁及以上成人和儿童患者中需要系统性治疗的PIK3CA相关过度生长谱（PROS）严重表现。2024年4月24日进行中 Opdivo Qvantig（纳武利尤单抗透明质酸酶nvhy）制剂：作为单药治疗或作为静脉纳武利尤单抗与伊匹木单抗联合治疗后的单药治疗，用于治疗接受氟嘧啶、奥沙利铂和伊立替康治疗后进展的微卫星高度不稳定（MSI-H）或错配修复缺陷（dMMR）转移性结直肠癌成人患者。2024年12月27日已获传统批准（2025年10月27日） Opdivo Qvantig（纳武利尤单抗/透明质酸酶nvhy）剂型：用于治疗既往接受过索拉非尼治疗、并在接受静脉纳武利尤单抗和伊匹木单抗治疗后的成人肝细胞癌（HCC）患者。2024年12月27日传统批准授予（2025年10月27日） RETEVMO（selpercatinib）剂型：12岁及以上的成人和儿童患者，患有经FDA批准的检测方法检测出RET突变的晚期或转移性甲状腺髓样癌（MTC），需要全身治疗 2024年4月10日传统批准授予（2024年9月27日） RETEVMO（selpercatinib）剂型：12岁及以上的成人和儿童患者，患有经FDA批准的检测方法检测出RET基因融合的晚期或转移性甲状腺癌，需要全身治疗且对放射性碘难治（如果放射性碘适用） 2024年4月10日传统批准授予（2024年6月12日） RETEVMO（selpercatinib）剂型：患有携带RET基因融合的局部晚期或转移性实体瘤、在既往全身治疗期间或之后出现疾病进展或没有令人满意的替代治疗选择的成人患者 2024年4月10日传统批准授予（2026年7月14日） Rozlytrek（entrectinib）剂型：用于1月龄以上成人和儿童患者，其实体瘤经FDA批准的检测方法检出神经营养性酪氨酸受体激酶（NTRK）基因融合且无已知的获得性耐药突变，为转移性肿瘤或手术切除可能导致严重并发症，且在既往治疗后出现疾病进展或没有满意的替代治疗选择。2023年10月20日持续进行中 Keytruda（pembrolizumab）给药方案：每6周400mg的替代剂量/方案，用于成人黑色素瘤、肝细胞癌、默克尔细胞癌、胃癌、非小细胞肺癌、肾细胞癌、子宫内膜癌、宫颈癌、尿路上皮癌、头颈部鳞状细胞癌、小细胞肺癌、食管癌、微卫星高度不稳定或错配修复缺陷实体瘤患者2020年4月28日获得传统批准（2022年12月16日） Keytruda（pembrolizumab）给药方案：每6周400mg的替代剂量/方案，用于成人经典型霍奇金淋巴瘤和原发纵隔B细胞淋巴瘤患者2020年4月28日获得传统批准（2025年7月24日） Keytruda（pembrolizumab）给药方案：每6周400mg的替代剂量/方案，用于成人皮肤鳞状细胞癌患者2020年6月24日获得传统批准（2022年12月16日） Romidepsin剂型：用于治疗既往至少接受过一种治疗的成人外周T细胞淋巴瘤2020年3月13日撤回（2021年12月8日） Zinecard（右雷佐生盐酸盐）支持治疗：预防与多柔比星给药相关的心肌病1995年5月26日获批传统批准（2002年10月31日） Keytruda（帕博利珠单抗）给药方案：针对不可切除或转移性肿瘤突变负荷高［≥10个突变/兆碱基（mut/Mb）］的成人实体瘤患者（由FDA批准的检测确定），且在既往治疗后出现进展且无满意替代治疗选择者，采用每6周400 mg的替代剂量/给药方案2020年6月16日获批传统批准（2022年12月16日） Afinitor Disperz（依维莫司）剂型：儿童和成人结节性硬化症复合体患者，用于治疗需要治疗干预但无法治愈性切除的室管膜下巨细胞星形细胞瘤2012年8月29日获批传统批准（2016年1月29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，以先到者为准。 内容截至： 2026年10月23日 受监管产品 药品
正文 · 英文原文
Other | 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 granted for supportive care products and changes to dosing or formulation. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. Drug NameAccelerated Approval IndicationAccelerated Approval DateCurrent Status 1 Lunsumio Velo (mosunetuzumab-axgb) Formulation: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.12/19/2025Ongoing Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)Formulation: Treatment of adult and pediatric patients 12 years and older with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 9/19/2025Traditional Approval Granted (10/16/2026) Brukinsa (zanubrutinib)Formulation: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.6/10/2025Ongoing Brukinsa (zanubrutinib)Formulation: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen.6/10/2025Ongoing Brukinsa (zanubrutinib)Formulation: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.6/10/2025Ongoing Vitrakvi (larotrectinib)Formation: Treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative treatments or that have progressed following treatment11/26/2018Traditional Approval Granted (04/09/2025) Vijoice (alpelisib)Formulation: Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. 4/24/2024Ongoing Opdivo Qvantig (nivolumab hyaluronidase nvhy)Formulation: As monotherapy or as monotherapy following treatment with intravenous nivolumab and ipilimumab combination therapy for the treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.12/27/2024Traditional Approval Granted (10/27/2025) Opdivo Qvantig (nivolumab hyaluronidase nvhy)Formulation: Treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib and following treatment with intravenous nivolumab and ipilimumab.12/27/2024Traditional Approval Granted (10/27/2025) RETEVMO (selpercatinib)Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy 4/10/2024Traditional Approval Granted (09/27/2024) RETEVMO (selpercatinib)Formulation: Adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) 4/10/2024Traditional Approval Granted (06/12/2024) RETEVMO (selpercatinib)Formulation: Adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options 4/10/2024Traditional Approval Granted (07/14/2026) Rozlytrek (entrectinib)Formulation: Adult and pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation as detected by an FDA-approved test, are metastatic or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory alternative therapy.10/20/2023Ongoing Keytruda (pembrolizumab)Dosing Regimen: Alternative dose/schedule of 400mg every 6 weeks for adult patients with melanoma, hepatocellular carcinoma, Merkel cell carcinoma, gastric cancer, non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, cervical carcinoma, urothelial carcinoma, head and neck squamous cell carcinoma, small cell lung cancer, esophageal cancer, microsatellite instability-high or mismatch repair deficient solid tumors4/28/2020Traditional Approval Granted (12/16/2022) Keytruda (pembrolizumab)Dosing Regimen: Alternative dose/schedule of 400 mg every 6 weeks for adult patients with classical Hodgkin lymphoma and primary mediastinal b-cell lymphoma4/28/2020Traditional Approval Granted (07/24/2025) Keytruda (pembrolizumab)Dosing Regimen: Alternative dose/schedule of 400mg every 6 weeks for adult patients with cutaneous squamous cell carcinoma6/24/2020Traditional Approval Granted (12/16/2022) RomidepsinFormulation: Treatment of peripheral T-cell lymphoma in adults who have received at least one prior therapy3/13/2020Withdrawn (12/08/2021) Zinecard (dexrazoxane hydrochloride)Supportive Care: Prevention of cardiomyopathy associated with doxorubicin administration5/26/1995Traditional Approval Granted (10/31/2002) Keytruda (pembrolizumab)Dosing Regimen: Alternate Dose/Schedule of 400 mg every 6 weeks for adult patients with unresectable or metastatic tumor mutational burden high [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options6/16/2020Traditional Approval Granted (12/16/2022) Afinitor Disperz (everolimus)Formulation: Pediatric and adult patients with tuberous sclerosis complex for treatment of subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected8/29/2012Traditional Approval Granted (01/29/2016) 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: 10/23/2026 Regulated Product(s) Drugs
摘要 待译
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation.