Verified Clinical Benefit | Cancer Accelerated Approvals
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已验证临床获益 | 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病和肿瘤适应症的加速批准（AA），这些批准具有已验证临床获益的上市后试验，并且随后已针对特定适应症获得传统批准。请参阅Drugs@FDA以获取特定产品的最新批准和处方信息。访问进行中或已撤回的AA适应症页面以获取更多信息。 药物名称加速批准（AA）适应症加速批准日期传统批准日期 Keytruda（pembrolizumab）用于治疗经FDA批准的检测确定、既往治疗后进展且无满意替代治疗方案的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）]实体瘤的成年和儿童患者。6/16/202010/16/2026 Breyanzi（lisocabtagene maraleucel）接受过两线或以上既往系统性治疗的复发或难治性滤泡性淋巴瘤（FL）成年患者5/15/20242/20/2026 Tecartus（brexucabtagene autoleucel）用于治疗复发或难治性套细胞淋巴瘤（MCL）成年患者。7/24/20204/1/2026 Retevmo（selpercatinib）用于患有局部晚期或转移性实体瘤、携带RET基因融合、且在先前的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方案的成人患者 *9/21/20227/14/2026 Opdivo（nivolumab）用于治疗成人在以下情况后复发或进展的经典型霍奇金淋巴瘤： 自体造血干细胞移植（HSCT）和brentuximab vedotin，或 包括自体HSCT在内的3线或以上全身治疗 4/25/20173/20/2026 Opdivo（nivolumab）用于治疗在自体造血干细胞移植（HSCT）及移植后brentuximab vedotin后复发或进展的经典型霍奇金淋巴瘤5/17/20163/20/2026 Tecvayli（teclistamab-cqyv）用于已接受至少四线既往治疗（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10/25/20223/5/2026 Braftovi（encorafenib）与西妥昔单抗和mFOLFOX6联合，用于治疗经FDA批准检测发现携带BRAF V600E突变的转移性结直肠癌（mCRC）患者12/20/20242/24/2026 Rubraca（rucaparib）用于治疗已接受雄激素受体靶向治疗和以紫杉烷为基础的化疗、携带致病性BRCA突变（胚系和/或体细胞）相关的转移性去势抵抗性前列腺癌（mCRPC）成人患者5/15/202012/17/2025 Zynyz（retifanlimab-dlwr）用于患有转移性或复发性局部晚期梅克尔细胞癌（MCC）的成人患者 2023年3月22日 2025年12月17日 Jayprica（pirtobrutinib）用于已接受至少两线既往治疗（包括一种BTK抑制剂和一种BCL-2抑制剂）的慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）成人患者 2023年12月1日 2025年12月2日 Darzalex Faspro（daratumumab与透明质酸酶-fihj）与硼替佐米、环磷酰胺和地塞米松联合，用于新诊断的轻链（AL）淀粉样变性患者的治疗 2021年1月15日 2025年11月19日 Imdelltra（tarlatamab-dlle）用于在接受铂类化疗期间或之后出现疾病进展的广泛期小细胞肺癌（ES-SCLC）成人患者 2024年5月16日 2025年11月19日 Epkinly（epcoritamab-bysp）用于在接受两线或以上系统性治疗后复发或难治性滤泡性淋巴瘤（FL）成人患者的治疗 2024年6月24日 2025年11月18日 Yervoy（ipilimumab）与纳武利尤单抗联合，用于既往接受过索拉非尼治疗的肝细胞癌（HCC）患者的治疗 2020年3月10日 2025年4月11日 Opdivo（nivolumab）与伊匹木单抗联合，用于既往接受过索拉非尼治疗的肝细胞癌（HCC）患者的治疗 2020年3月10日 2025年4月11日 Vitrakvi（larotrectinib）用于治疗患有神经滋养型酪氨酸受体激酶（NTRK）基因融合且无已知获得性耐药突变的实体瘤的成人和儿童患者；这些患者为转移性或手术切除可能导致严重并发症；且没有满意的替代治疗或治疗后出现进展11/26/20184/09/2025 Opdivo（nivolumab）用于治疗12岁及以上患有微卫星不稳定高（MSI-H）或错配修复缺陷（dMMR）转移性结直肠癌（CRC）的成人和儿童患者，这些患者在氟嘧啶、奥沙利铂和伊立替康治疗后出现进展7/31/20174/08/2025 Opdivo（nivolumab）与ipilimumab联合，适用于治疗12岁及以上患有微卫星不稳定高（MSI-H）或DNA错配修复缺陷（dMMR）、转移性结直肠癌的成人和儿童患者，这些患者在氟嘧啶、奥沙利铂和伊立替康治疗后出现进展7/10/20184/08/2025 Yervoy（ipilimumab）与nivolumab联合，适用于治疗12岁及以上患有微卫星不稳定高（MSI-H）或DNA错配修复缺陷（dMMR）、转移性结直肠癌的成人和儿童患者，这些患者在氟嘧啶、奥沙利铂和伊立替康治疗后出现进展7/10/20184/08/2025 Keytruda（帕博利珠单抗）联合曲妥珠单抗及含氟嘧啶和铂类化疗，用于局部晚期不可切除或转移性HER2阳性胃或胃食管交界处（GEJ）腺癌患者的一线治疗 1 5/5/20213/19/2025 Calquence（阿可替尼）用于治疗既往接受过至少一种治疗的成人套细胞淋巴瘤（MCL）患者10/31/20171/16/2025 Retevmo（塞尔帕替尼）用于需要全身治疗的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 *5/8/20209/27/2024 Retevmo（塞尔帕替尼）用于需要全身治疗且放射性碘难治（如放射性碘适用）的12岁及以上晚期或转移性RET融合阳性甲状腺癌成人和儿童患者 *5/8/20206/12/2024 Tivdak（替索单抗维多汀-tftv）用于治疗化疗期间或化疗后疾病进展的复发性或转移性宫颈癌成人患者9/20/20214/29/2024 Elahere（米妥昔单抗索拉夫坦辛-gynx）用于叶酸受体α（FRα）阳性、铂类耐药的上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者，且既往接受过一至三种全身治疗方案。根据FDA批准的检测方法选择患者进行治疗11/14/20223/22/2024 Rybrevant（amivantamab-vmjw）用于治疗经FDA批准的检测方法检测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，这些患者在含铂化疗期间或之后出现疾病进展 5/21/2021 3/1/2024 Tepmetko（tepotinib）用于治疗携带间充质-上皮转化（MET）外显子14跳跃改变的转移性非小细胞肺癌（NSCLC）成人患者。2/3/2021 2/15/2024 Keytruda（pembrolizumab）用于治疗既往接受过索拉非尼治疗的肝细胞癌（HCC）患者 11/9/2018 1/25/2024 Balversa（erdafitinib）用于治疗患有局部晚期或转移性尿路上皮癌（mUC）的成人患者，该疾病具有： 易感FGFR3或FGFR2基因改变，且 在至少一线既往含铂化疗期间或之后出现进展，包括在新辅助或辅助含铂化疗后12个月内。根据FDA批准的BALVERSA伴随诊断方法选择患者接受治疗。 4/12/2019 1/19/2024 Padcev（enfortumab vedotin-efjv）与pembrolizumab联合用于治疗不适合含顺铂化疗的局部晚期或转移性尿路上皮癌成人患者 4/3/2023 12/15/2023 Keytruda（帕博利珠单抗）联合enfortumab vedotin-ejfv，用于治疗不适合含顺铂化疗的局部晚期或转移性尿路上皮癌成人患者 2023年4月3日 2023年12月15日 Keytruda（帕博利珠单抗）用于治疗成人和儿童复发性局部晚期或转移性默克尔细胞癌（MCC）患者 2018年12月19日 2023年10月12日 Bavencio（阿维鲁单抗）用于治疗12岁及以上成人和儿童转移性默克尔细胞癌（MCC）患者 2017年3月23日 2023年9月6日 Gavreto（普拉替尼）用于治疗经FDA批准的检测方法检出的转移性RET融合阳性非小细胞肺癌（NSCLC）成人患者 2020年9月4日 2023年8月9日 Blincyto（贝林妥欧单抗）用于治疗成人和儿童CD19阳性B细胞前体急性淋巴细胞白血病（ALL），患者处于首次或第二次完全缓解且微小残留病（MRD）大于或等于0.1% 2018年3月29日 2023年6月20日 Libtayo（西米普利单抗-rwlc）用于既往接受过hedgehog通路抑制剂治疗或不适合使用hedgehog通路抑制剂的转移性基底细胞癌（mBCC）患者 2021年2月9日 2023年4月28日 Polivy（polatuzumab vedotin-piiq）联合苯达莫司汀和一种利妥昔单抗产品，用于既往至少接受过两种治疗后复发或难治性非特指型弥漫性大B细胞淋巴瘤（DLBCL）的成人患者。2019年6月10日 2023年4月19日 可瑞达（帕博利珠单抗）用于治疗既往治疗后进展且无满意替代治疗方案的不可切除或转移性微卫星高度不稳定（MSI-H）或错配修复缺陷（dMMR）实体瘤的成人和儿童患者，或含氟尿嘧啶、奥沙利铂和伊立替康方案治疗后进展的转移性MSI-H或dMMR结直肠癌 5/23/2017 3/28/2023 Jemperli（多塔利单抗-gxly）用于经FDA批准的检测确定、含铂方案治疗期间或之后进展的错配修复缺陷（dMMR）复发性或晚期子宫内膜癌（EC）成人患者。4/22/2021 2/9/2023 Scemblix（阿思尼布）用于既往接受过2种或以上酪氨酸激酶抑制剂（TKI）治疗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 10/29/2021 10/12/2022 Retevmo（塞普替尼）用于转移性RET融合阳性非小细胞肺癌（NSCLC）成人患者 5/8/2020 09/21/2022 Tabrecta（卡马替尼）用于经FDA批准的检测发现肿瘤存在导致MET外显子14跳跃突变的mNSCLC成人患者 5/6/2020 8/10/2022 Clolar（氯法拉滨）用于治疗既往至少接受过2种方案后复发或难治性急性淋巴细胞白血病（ALL）的1至21岁儿童患者 12/28/2004 7/18/2022 Enhertu（Fam-trastuzumab deruxtecan-nxki）适用于在转移性疾病阶段已接受过两种或以上抗HER2方案的不可切除或转移性HER2阳性乳腺癌成人患者 12/20/2019 5/4/2022 Keytruda（pembrolizumab）与化疗联合，用于经FDA批准的检测确定PD-L1表达[CPS=10]的局部复发不可切除或转移性TNBC 11/13/2020 7/26/2021 Trodelvy（sacituzumab govitecan-hziy）适用于转移性疾病接受过至少2种既往治疗后的转移性TNBC成人患者 4/22/2020 4/7/2021 Padcev（enfortumab vedotin-ejfv）适用于在新辅助、局部晚期或转移性疾病阶段接受过PD-1或PD-L1抑制剂及含铂化疗的局部晚期或转移性尿路上皮癌成人患者 12/18/2019 7/9/2021 Keytruda（pembrolizumab）与仑伐替尼联合，用于非MSI-H或dMMR的晚期子宫内膜癌，在全身治疗后进展且不适合根治性手术或放疗者 9/17/2019 7/21/2021 Lenvima（仑伐替尼）与帕博利珠单抗联合，用于非MSI-H或dMMR的晚期子宫内膜癌，在全身治疗后进展且不适合根治性手术或放疗者 9/17/2019 7/21/2021 Xpovio（selinexor）与地塞米松联合，用于既往接受过至少4种治疗且对至少2种蛋白酶体抑制剂、2种免疫调节剂和一种抗CD38单克隆抗体难治的复发/难治性多发性骨髓瘤成人患者 7/3/2019 12/18/2020 Venclexta（维奈克拉）与阿扎胞苷或地西他滨或低剂量阿糖胞苷联合，用于年龄≥75岁或存在妨碍使用强化诱导化疗的合并症的新诊断成人急性髓系白血病11/21/201810/16/2020 Lorbrena（劳拉替尼）ALK阳性转移性非小细胞肺癌，且在以下治疗后进展： • 克唑替尼和至少一种其他ALK抑制剂用于转移性疾病；或 • 阿来替尼作为转移性疾病的首个ALK抑制剂治疗；或 • 色瑞替尼作为转移性疾病的首个ALK抑制剂治疗11/2/20183/3/2021 Keytruda（帕博利珠单抗）成人及儿童难治性原发性纵隔大B细胞淋巴瘤患者，或既往接受≥2线治疗后复发者6/13/201810/14/2020 Keytruda（帕博利珠单抗）用于治疗化疗期间或化疗后疾病进展的复发性或转移性宫颈癌患者，其肿瘤经FDA批准的检测确定表达PD-L1（CPS >/=1）6/12/201810/13/2021 Alimta（培美曲塞二钠）与帕博利珠单抗和卡铂联合，用于转移性非鳞状非小细胞肺癌的一线治疗6/4/20181/30/2019 Bosulif（博舒替尼）新诊断慢性期费城染色体阳性慢性髓性白血病成人患者12/19/20175/14/2021 Keytruda（帕博利珠单抗）不适合含顺铂化疗的局部晚期或转移性尿路上皮癌15/18/20178/31/2021 Keytruda（帕博利珠单抗）与培美曲塞和卡铂联合，用于转移性非鳞状非小细胞肺癌的一线治疗5/10/20178/20/2018 Bavencio（avelumab）：含铂化疗期间或之后疾病进展的局部晚期或转移性尿路上皮癌，或含铂化疗新辅助或辅助治疗后12个月内疾病进展 2017年5月9日 2020年6月30日 Alunbrig（brigatinib）：ALK阳性转移性非小细胞肺癌（NSCLC）患者，既往接受克唑替尼治疗后进展或不耐受 2017年4月28日 2020年5月22日 Keytruda（pembrolizumab）：成人及儿童难治性经典型霍奇金淋巴瘤患者，或既往接受3线及以上治疗后复发的患者 2017年3月14日 2020年10月14日 Opdivo（nivolumab）：局部晚期或转移性尿路上皮癌，符合以下情况：• 含铂化疗期间或之后进展 • 含铂化疗新辅助或辅助治疗后12个月内进展 2017年2月2日 2021年8月19日 Rubraca（rucaparib）：携带有害BRCA突变（胚系和/或体细胞）的晚期卵巢癌，既往接受2种或以上化疗 2016年12月19日 2018年4月6日 Keytruda（pembrolizumab）：复发或转移性头颈部鳞状细胞癌，含铂化疗期间或之后进展 2016年8月5日 2019年6月10日 Venclexta（venetoclax）：经FDA批准的检测方法检出17P缺失的慢性淋巴细胞白血病，既往至少接受过一种治疗 2016年4月11日 2018年6月8日 Opdivo（纳武利尤单抗）1）与伊匹木单抗联合用于不可切除或转移性黑色素瘤，取消仅限治疗BRAF野生型黑色素瘤患者的限制；2）作为单药用于BRAF V600突变阳性不可切除或转移性黑色素瘤，取消此类患者须在伊匹木单抗和BRAF抑制剂治疗后出现疾病进展的限制1/23/20163/7/2019 Alecensa（阿来替尼）ALK阳性转移性非小细胞肺癌（NSCLC），在接受克唑替尼治疗后进展或不耐受12/11/201511/6/2017 Darzalex（达雷妥尤单抗）多发性骨髓瘤，既往至少接受过3线治疗（包括蛋白酶体抑制剂和免疫调节剂），或对蛋白酶体抑制剂和免疫调节剂双重难治11/16/201511/21/2016 Tagrisso（奥希替尼）经FDA批准的检测方法检测为EGFR T790M突变阳性的转移性NSCLC，在EGFR酪氨酸激酶抑制剂（TKI）治疗期间或之后进展11/13/20153/30/2017 Keytruda（帕博利珠单抗）经FDA批准的检测方法确定为PD-L1阳性的转移性NSCLC，在含铂化疗期间或之后进展10/2/201510/24/2016 Opdivo（纳武利尤单抗）与伊匹木单抗联合用于BRAF V600野生型不可切除或转移性黑色素瘤9/30/20153/7/2019 Ibrance（哌柏西利）与来曲唑联合用于绝经后雌激素受体（ER）阳性、人表皮生长因子受体2（HER2）阴性晚期乳腺癌女性，作为转移性疾病的首个以内分泌为基础的疗法2/3/20153/31/2017 Opdivo（纳武利尤单抗）不可切除或转移性黑色素瘤，且在伊匹木单抗治疗后进展，若BRAF V600突变阳性，则在BRAF抑制剂治疗后12/22/20143/7/2019 Lynparza（奥拉帕利）在接受3线或以上化疗后出现有害或疑似有害种系BRCA突变的晚期卵巢癌 212/19/20148/17/2017 Blincyto（贝林妥欧单抗）费城染色体阴性复发或难治性B细胞前体急性淋巴细胞白血病12/3/20147/11/2017 Keytruda（帕博利珠单抗）不可切除或转移性黑色素瘤，且在伊匹木单抗治疗后疾病进展，若BRAF V600突变阳性，则在BRAF抑制剂治疗后9/4/201412/18/2015 Zykadia（塞瑞替尼）ALK阳性转
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Verified Clinical Benefit | 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 with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. Visit the ongoing or withdrawn AA indication pages for more information. Drug NameAccelerated Approval (AA) IndicationAccelerated Approval DateTraditional Approval Date Keytruda (pembrolizumab)Treatment of adult and pediatric patients 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.6/16/202010/16/2026 Breyanzi (lisocabtagene maraleucel) Adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy5/15/20242/20/2026 Tecartus (brexucabtagene autoleucel)Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).7/24/20204/1/2026 Retevmo (selpercatinib)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 *9/21/20227/14/2026 Opdivo (nivolumab) Treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: Autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, Or 3 or more lines of systemic therapy that includes autologous HSCT 4/25/20173/20/2026 Opdivo (nivolumab)For the treatment of classical Hodgkin Lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin5/17/20163/20/2026 Tecvayli (teclistamab-cqyv)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 antibody10/25/20223/5/2026 Braftovi (encorafenib)In combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test12/20/20242/24/2026 Rubraca (rucaparib)Treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy5/15/202012/17/2025 Zynyz (retifanlimab-dlwr)Adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)3/22/202312/17/2025 Jayprica (pirtobrutinib)Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor12/1/202312/2/2025 Darzalex Faspro (daratumumab and hyaluronidase-fihj)Treatment of patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients1/15/202111/19/2025 Imdelltra (tarlatamab-dlle)Adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy5/16/202411/19/2025 Epkinly (epcoritamab-bysp)Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy6/24/202411/18/2025 Yervoy (ipilimumab)In combination with nivolumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib3/10/20204/11/2025 Opdivo (nivolumab)In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib3/10/20204/11/2025 Vitrakvi (larotrectinib)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 treatment11/26/20184/09/2025 Opdivo (nivolumab)For the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan7/31/20174/08/2025 Opdivo (nivolumab)In combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan7/10/20184/08/2025 Yervoy (ipilimumab)In combination with nivolumab, is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or DNA mismatch repair deficient (dMMR), metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan7/10/20184/08/2025 Keytruda (pembrolizumab)In combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma 1 5/5/20213/19/2025 Calquence (acalabrutinib)Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy10/31/20171/16/2025 Retevmo (selpercatinib)Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy *5/8/20209/27/2024 Retevmo (selpercatinib)Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) *5/8/20206/12/2024 Tivdak (tisotumab vedotin-tftv)Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy9/20/20214/29/2024 Elahere (mirvetuximab soravtansine-gynx)Adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test11/14/20223/22/2024 Rybrevant (amivantamab-vmjw)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 test, whose disease has progressed on or after platinum based chemotherapy5/21/20213/1/2024 Tepmetko (tepotinib)Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.2/3/20212/15/2024 Keytruda (pembrolizumab)Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib11/9/20181/25/2024 Balversa (erdafitinib)Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has: susceptible FGFR3 or FGFR2 genetic alterations, and progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. 4/12/20191/19/2024 Padcev (enfortumab vedotin-efjv)In combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy4/3/202312/15/2023 Keytruda (pembrolizumab)In combination with enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy4/3/202312/15/2023 Keytruda (pembrolizumab) Treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)12/19/201810/12/2023 Bavencio (avelumab)Treatment of adults and pediatrics patients 12 years and older with metastatic merkel cell carcinoma (MCC)3/23/20179/6/2023 Gavreto (pralsetinib)Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test9/4/20208/9/2023 Blincyto (blinatumomab)Treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children 13/29/20186/20/2023 Libtayo (cemiplimab-rwlc)Patients with metastatic basal cell carcinoma (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate2/9/20214/28/2023 Polivy (polatuzumab vedotin- piiq)In combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.6/10/20194/19/2023 Keytruda (pembrolizumab)Treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or metastatic MSI-H or dMMR colorectal cancer that have progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan5/23/20173/28/2023 Jemperli (dostarlimab-gxly) Adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC), as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen.4/22/20212/9/2023 Scemblix (asciminib)Adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)10/29/202110/12/2022 Retevmo (selpercatinib)Adult patients with metastatic RET fusion-positive Non-Small Cell Lung Cancer (NSCLC) 5/8/202009/21/2022 Tabrecta (capmatinib) Adult patients with mNSCLC whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test5/6/20208/10/2022 Clolar (clofarabine)Treatment of pediatric patients 1 to 21 yrs old with relapsed or refractory acute lymphocytic leukemia (ALL) after at least 2 prior regimens12/28/20047/18/2022 Enhertu (Fam-trastuzumab deruxtecan-nxki)Adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting 12/20/20195/4/2022 Keytruda (pembrolizumab)In combination with chemotherapy for locally recurrent unresectable or metastatic TNBC expressing PD L1 [CPS =10] as determined by an FDA-approved test11/13/20207/26/2021 Trodelvy (sacituzumab govitecan-hziy)Adults with metastatic TNBC following at least 2 prior therapies for metastatic disease4/22/20204/7/2021 Padcev (enfortumab vedotin-ejfv)Adults with locally advanced or metastatic urothelial cancer who received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant, locally advanced, or metastatic setting12/18/20197/9/2021 Keytruda (pembrolizumab)In combination with lenvatinib for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiation9/17/20197/21/2021 Lenvima (lenvatinib)In combination with pembrolizumab for advanced endometrial carcinoma not MSI-H or dMMR, with progression following systemic therapy and not candidates for curative surgery or radiation9/17/20197/21/2021 Xpovio (selinexor)In combination with dexamethasone for adults with relapsed/refractory multiple myeloma after at least 4 prior therapies and refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody7/3/201912/18/2020 Venclexta (venetoclax)In combination with azacitidine or decitabine or low-dose cytarabine for newly-diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy11/21/201810/16/2020 Lorbrena (lorlatinib)ALK-positive metastatic NSCLC that has progressed on: • Crizotinib and at least one other ALK inhibitor for metastatic disease; or • Alectinib as the first ALK inhibitor therapy for metastatic disease; or • Ceritinib as the first ALK inhibitor therapy for metastatic disease11/2/20183/3/2021 Keytruda (pembrolizumab)Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after 2 or more prior lines of therapy6/13/201810/14/2020 Keytruda (pembrolizumab)Treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS >/=1) as determined by an FDA approved test6/12/201810/13/2021 Alimta (pemetrexed disodium)In combination with pembrolizumab and carboplatin for first-line treatment of metastatic non-squamous NSCLC6/4/20181/30/2019 Bosulif (bosutinib)Adults with newly diagnosed chronic phase Philadelphia chromosome positive CML12/19/20175/14/2021 Keytruda (pembrolizumab)Locally advanced or metastatic urothelial carcinoma ineligible for cisplatin-containing chemotherapy 15/18/20178/31/2021 Keytruda (pembrolizumab)In combination with pemetrexed and carboplatin for first-line treatment of metastatic non-squamous NSCLC5/10/20178/20/2018 Bavencio (avelumab)Locally advanced or metastatic urothelial carcinoma following diease progression on platinum-containing chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy5/9/20176/30/2020 Alunbrig (brigatinib)Patients with ALK-positive metastatic NSCLC that have progressed or are intolerant to crizotinib4/28/20175/22/2020 Keytruda (pembrolizumab)Adult and pediatric patients with refractory classical Hodgkin Lymphoma or who have relapsed after 3 or more prior lines of therapy3/14/201710/14/2020 Opdivo (nivolumab)Locally advanced or metastatic urothelial carcinoma that: • progressed during or following platinum-containing chemotherapy • progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy2/2/20178/19/2021 Rubraca (rucaparib)Deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer treated with 2 or more chemotherapies 212/19/20164/6/2018 Keytruda (pembrolizumab)Recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy8/5/20166/10/2019 Venclexta (venetoclax)Chronic lymphocytic leukemia with 17P deletion as detected by an FDA-approved test, after at least one prior therapy4/11/20166/8/2018 Opdivo (nivolumab)1) In combination with ipilimumab for unresectable or metastatic melanoma to remove the restriction for treatment of only patients with BRAF wild-type melanoma; 2) As a single agent for BRAF V600 mutation positive unresectable or metastatic melanoma to remove the restriction that such patients should have disease progression following ipilimumab and a BRAF inhibitor1/23/20163/7/2019 Alecensa (alectinib)ALK-positive metastatic NSCLC that progressed on or is intolerant to crizotinib12/11/201511/6/2017 Darzalex (daratumumab)Multiple myeloma after at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or double refractory to a proteasome inhibitor and an immunomodulatory agent11/16/201511/21/2016 Tagrisso (osimertinib)Metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, that progressed on or after EGFR TKI therapy11/13/20153/30/2017 Keytruda (pembrolizumab)Metastatic PD-L1 positive NSCLC, as determined by an FDA-approved test, with progression on or after platinum-containing chemotherapy10/2/201510/24/2016 Opdivo (nivolumab)In combination with ipilimumab for BRAF V600 wild-type unresectable or metastatic melanoma9/30/20153/7/2019 Ibrance (palbociclib)In combination with letrozole for postmenopausal women with ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease2/3/20153/31/2017 Opdivo (nivolumab)Unresectable or metastatic melanoma and progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor12/22/20143/7/2019 Lynparza (olaparib)Deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer after treatment with 3 or more lines of chemotherapy 212/19/20148/17/2017 Blincyto (blinatumomab)Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia12/3/20147/11/2017 Keytruda (pembrolizumab)Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor9/4/201412/18/2015 Zykadia (ceritinib)ALK-positive met
摘要 待译
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.