Oncology (Cancer)/Hematologic Malignancies Approval Notifications
正文 · 中文译文
肿瘤（癌症）/血液系统恶性肿瘤批准通知 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 FDA不会对肿瘤学和血液学领域发生的每一次批准或药品标签更新发布批准公告。请参阅Drugs@FDA以获取特定产品的最新批准和处方信息。 网页描述日期 FDA授予amivantamab和透明质酸酶-lpuj加速批准，用于复发或转移性头颈部鳞状细胞癌 2026年11月5日，美国食品药品监督管理局授予amivantamab和透明质酸酶-lpuj（Rybrevant Faspro，Janssen Biotech， Inc.）加速批准，用于成人复发或转移性头颈部鳞状细胞癌（HNSCC）患者，这些患者的疾病在含铂化疗和抗PD-(L)1抗体治疗后或之后出现进展。amivantamab和透明质酸酶-lpuj不适用于HPV相关的口咽鳞状细胞癌（OPSCC）患者。11/5/2026 FDA批准他拉唑帕利联合恩扎卢胺用于治疗携带HRR基因突变、转移性雄激素通路调节初治或敏感的前列腺癌 2026年10月26日，美国食品药品监督管理局（FDA）批准他拉唑帕利（Talzenna，辉瑞公司）联合恩扎卢胺，用于治疗经FDA授权检测发现携带同源重组修复（HRR）基因突变的转移性雄激素通路调节初治或敏感（mAPMN/S）前列腺癌成人患者。2026/10/26 FDA授予帕博利珠单抗或帕博利珠单抗联合berahyaluronidase alfa-pmph传统批准，用于不可切除或转移性TMB-H实体瘤并更新适应证 2026年10月16日，美国食品药品监督管理局授予帕博利珠单抗（Keytruda，默克）或帕博利珠单抗联合berahyaluronidase alfa-pmph（Keytruda Qlex，默克）传统批准，用于成人和儿童不可切除或转移性肿瘤突变负荷高（TMB-H）[≥13个突变/兆碱基（mut/Mb）]实体瘤患者，该状态由FDA授权检测确定，且既往治疗后疾病进展且无满意替代治疗选择。2026/10/22 FDA授予多塔利单抗加速批准用于局部晚期直肠癌 2026年10月19日，美国食品药品监督管理局授予多塔利单抗（Jemperli，葛兰素史克）加速批准，用于患有II/III期局部晚期直肠癌（LARC）的成人患者，该肿瘤为微卫星高度不稳定（MSI-H）或错配修复缺陷（dMMR），由FDA授权的实体瘤检测确定。2026/10/19 FDA批准扩展nogapendekin alfa inbakicept-pmln用于BCG无应答非肌层浸润性膀胱癌的适应证。2026年10月14日，美国食品药品监督管理局（FDA）批准nogapendekin alfa inbakicept-pmln（Anktiva，Altor BioScience， LLC，ImmunityBio， Inc.的间接全资子公司）联合卡介苗（BCG）用于BCG无应答非肌层浸润性膀胱癌（NMIBC）成人患者。此次修订将既往用于伴或不伴乳头状肿瘤的原位癌（CIS）BCG无应答NMIBC成人患者的适应证扩展至仅伴高级别乳头状肿瘤的患者。2026年10月14日 FDA批准阿替利珠单抗联合化疗用于III期错配修复缺陷结肠癌。2026年10月8日，美国食品药品监督管理局批准阿替利珠单抗（Tecentriq， Genentech， Inc.）联合氟嘧啶和奥沙利铂用于2岁及以上III期错配修复缺陷（dMMR）结肠癌成人和儿童患者的辅助治疗。FDA还批准阿替利珠单抗和透明质酸酶-tqjs（Tecentriq Hybreza， Genentech， Inc.）联合氟嘧啶和奥沙利铂用于12岁及以上、体重40 kg或以上的III期dMMR结肠癌成人和儿童患者的辅助治疗。2026年10月8日 FDA批准图卡替尼联合曲妥珠单抗和帕妥珠单抗用于HER2阳性乳腺癌的维持治疗2026年10月7日，美国食品药品监督管理局（FDA）批准图卡替尼（Tukysa，Seagen公司，辉瑞子公司）联合曲妥珠单抗和帕妥珠单抗，用于成人不可切除的局部晚期或转移性HER2阳性乳腺癌患者在诱导治疗后的维持治疗。2026年10月7日 FDA批准匹妥布替尼用于既往未经治疗的慢性淋巴细胞白血病或小淋巴细胞淋巴瘤2026年10月2日，美国食品药品监督管理局批准匹妥布替尼（Jaypirca，礼来公司）用于既往未经治疗且无已知17p缺失的成人慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）患者。2026年10月2日 FDA批准贝组替凡联合仑伐替尼用于伴透明细胞成分的晚期肾细胞癌2026年9月24日，美国食品药品监督管理局批准贝组替凡（Welireg，默克公司）联合仑伐替尼（Lenvima，卫材公司）用于在接受程序性死亡受体-1（PD-1）或程序性死亡配体1（PD-L1）抑制剂治疗后伴透明细胞成分的晚期肾细胞癌（ccRCC）成人患者。2026年9月24日 FDA批准lirafugratinib用于经治的不可切除、局部晚期或转移性胆管癌 2026年9月23日，美国食品药品监督管理局（FDA）批准lirafugratinib（Lyrfigtu，Elevar Therapeutics, Inc.）——一种激酶抑制剂——用于治疗既往接受过治疗、不可切除、局部晚期或转移性、携带成纤维细胞生长因子受体2（FGFR2）基因融合或其他重排的成人胆管癌。2026年9月23日 FDA批准imlunestrant联合阿贝西利用于ER阳性、HER2阴性、ESR1突变的晚期或转移性乳腺癌 2026年9月18日，美国食品药品监督管理局（FDA）批准imlunestrant（Inluriyo）联合阿贝西利（Verzenio），用于经FDA授权检测发现雌激素受体（ER）阳性、人表皮生长因子受体2（HER2）阴性、雌激素受体1（ESR1）突变的晚期或转移性乳腺癌成人患者，且在接受至少一线内分泌治疗后出现疾病进展。Inluriyo和Verzenio由礼来公司生产。2026年9月18日 FDA加速批准sevabertinib用于局部晚期或转移性非鳞状非小细胞肺癌2026年9月9日，美国食品药品监督管理局（FDA）加速批准激酶抑制剂sevabertinib（Hyrnuo，Bayer Healthcare Pharmaceuticals Inc.）用于经FDA授权检测发现肿瘤携带HER2（ERBB2）酪氨酸激酶结构域（TKD）激活突变的成人局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者。9/9/2026 FDA加速批准camizestrant联合CDK4/6抑制剂用于ESR1突变型HR阳性、HER2阴性局部晚期或转移性乳腺癌2026年9月4日，美国食品药品监督管理局加速批准雌激素受体拮抗剂camizestrant（Etcamah，AstraZeneca）联合CDK4/6抑制剂（abemaciclib、palbociclib或ribociclib），用于在芳香化酶抑制剂和CDK4/6抑制剂治疗期间经FDA授权检测发现雌激素受体1（ESR1）突变的成人激素受体（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患者。9/4/2026 FDA批准daraxonrasib用于转移性胰腺导管腺癌2026年8月26日，美国食品药品监督管理局（FDA）批准daraxonrasib（RASONQUE，Revolution Medicines，Inc.），一种RAS GTP酶家族抑制剂，用于既往接受过至少一种全身治疗或不适合多药全身治疗的成人转移性胰腺导管腺癌患者。2026/8/26 FDA批准zanidatamab-hrii和替雷利珠单抗-jsgr用于HER2阳性胃、胃食管结合部或食管腺癌2026年8月25日，美国食品药品监督管理局（FDA）批准zanidatamab-hrii（Ziihera，Jazz Pharmaceuticals） 联合含氟尿嘧啶和铂类化疗以及替雷利珠单抗-jsgr（Tevimbra，BeOne Medicines USA，Inc.），作为成人HER2阳性（IHC 3+或IHC 2+/ISH+）不可切除局部晚期或转移性胃、胃食管结合部或食管腺癌（经FDA批准的检测方法检测）的一线治疗，以及 联合含氟尿嘧啶和铂类化疗，作为成人HER2阳性（IHC 3+）不可切除局部晚期或转移性胃、胃食管结合部或食管腺癌（经FDA批准的检测方法检测）的一线治疗。： dolutegravir 2026/8/25 FDA授予iberdomide联合达雷妥尤单抗与透明质酸酶-fihj及地塞米松 accelerated approval 用于多发性骨髓瘤2026年8月13日，美国食品药品监督管理局（FDA）授予iberdomide（Zenbexus，百时美施贵宝公司）联合达雷妥尤单抗与透明质酸酶-fihj及地塞米松 accelerated approval，用于已接受过至少一线治疗（包括蛋白酶体抑制剂和免疫调节剂）的成人多发性骨髓瘤患者。2026/8/13 FDA授予vusolimogene oderparepvec-wtpg联合纳武利尤单抗 accelerated approval 用于黑色素瘤2026年8月6日，美国食品药品监督管理局（FDA）授予vusolimogene oderparepvec-wtpg（Tudriqev，Replimune公司）——一种经基因改造的溶瘤病毒疗法——联合纳武利尤单抗 accelerated approval，用于治疗在接受基于程序性死亡受体-1（PD-1）阻断抗体的方案期间出现疾病进展的不可切除晚期皮肤黑色素瘤成人患者。2026/8/6 FDA批准镥Lu 177 vipivotide tetraxetan联合雄激素受体通路抑制剂治疗转移性雄激素通路调节初治或敏感性前列腺癌 2026年7月31日，美国食品药品监督管理局（FDA）批准镥Lu 177 vipivotide tetraxetan（Pluvicto，诺华制药公司）联合雄激素受体通路抑制剂（ARPI）治疗前列腺特异性膜抗原（PSMA）阳性的转移性雄激素通路调节初治或敏感性（mAPMN/S）前列腺癌成人患者（既往称为转移性激素敏感性前列腺癌）。2026/7/31 FDA批准zidesamtinib用于ROS1阳性非小细胞肺癌 2026年7月22日，美国食品药品监督管理局批准zidesamtinib（Jideytro，Nuvalent公司）用于既往接受过至少一种ROS1酪氨酸激酶抑制剂（TKI）治疗的局部晚期或转移性ROS1阳性非小细胞肺癌（NSCLC）成人患者。2026/7/22 FDA批准gedatolisib联合氟维司群（联合或不联合哌柏西利）用于HR阳性、HER2阴性局部晚期或转移性乳腺癌 2026年7月14日，美国食品药品监督管理局批准gedatolisib（Revtorpyk，Celcuity公司）联合氟维司群（联合或不联合哌柏西利），用于激素受体（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，这些患者在转移阶段接受至少一线内分泌治疗期间或之后出现疾病进展，且未检测到PIK3CA突变。2026/7/14 FDA授予塞普替尼常规批准，用于局部晚期或转移性RET融合阳性实体瘤 2026年7月14日，美国食品药品监督管理局（FDA）授予塞普替尼（Retevmo，礼来公司）常规批准，用于成人和2岁及以上儿童患者，这些患者患有经FDA批准的检测方法检测出RET基因融合的局部晚期或转移性实体瘤，且在接受既往全身治疗后出现疾病进展或之后进展，或没有令人满意的替代治疗选择。7/14/2026 FDA批准帕博利珠单抗或帕博利珠单抗与berahyaluronidase alfa-pmph分别联合恩诺单抗维多汀-ejfv用于肌层浸润性膀胱癌 2026年7月10日，美国食品药品监督管理局批准帕博利珠单抗（Keytruda，默克）或帕博利珠单抗与berahyaluronidase alfa-pmph（Keytruda Qlex，默克）分别联合恩诺单抗维多汀-ejfv（Padcev，安斯泰来制药）作为新辅助治疗（手术前），随后在膀胱切除术后（切除膀胱的手术）进行辅助治疗，用于成人肌层浸润性膀胱癌（MIBC）。这将该方案在此 setting 中先前仅限于顺铂不合格患者的批准扩展至所有适合膀胱切除术的MIBC患者。7/10/2026 FDA批准isatuximab-irfc皮下注射用于多发性骨髓瘤适应症 2026年7月9日，美国食品药品监督管理局批准isatuximab-irfc（Sarclisa Escena，赛诺菲-安万特美国有限责任公司）皮下注射用于多发性骨髓瘤适应症。7/09/2026 FDA批准基于异体调节性T细胞的免疫疗法联合HSPC和T细胞-vldq，用于匹配供者造血干细胞移植治疗成人血液系统恶性肿瘤 2026年6月30日，美国食品药品监督管理局（FDA）批准基于异体调节性T细胞的免疫疗法联合造血干/祖细胞（HSPC）和T细胞-vldq（Tregzi，Orca Bio），用于采用清髓性预处理方案的匹配供者造血干细胞移植（HSCT），以实现造血和免疫重建并改善无慢性移植物抗宿主病（cGHVD）生存，用于治疗成人血液系统恶性肿瘤。6/30/2026 FDA批准sacituzumab govitecan-hziy作为单药及联合帕博利珠单抗用于三阴性乳腺癌一线治疗 2026年6月24日，美国食品药品监督管理局批准sacituzumab govitecan-hziy（Trodelvy，Gilead Sciences, Inc.）用于成人三阴性乳腺癌（TNBC）的两项适应证。6/24/2026 FDA批准哌柏西利联合曲妥珠单抗（联合或不联合帕妥珠单抗）及内分泌治疗用于HR阳性、HER2阳性转移性乳腺癌的维持治疗 2026年6月24日，美国食品药品监督管理局批准哌柏西利（Ibrance，Pfizer Inc.）联合曲妥珠单抗（联合或不联合帕妥珠单抗）及内分泌治疗，用于成人HR阳性、HER2阳性局部晚期或转移性乳腺癌诱导治疗后的维持治疗。6/24/2026 FDA批准卡匹色替联合阿比特龙和泼尼松用于PTEN缺陷型、未接受或对雄激素通路调节敏感的前列腺癌 2026年6月12日，美国食品药品监督管理局（FDA）批准卡匹色替（Truqap，阿斯利康）联合阿比特龙和泼尼松，用于治疗经FDA授权检测确认为PTEN缺陷型、转移性且未接受或对雄激素通路调节敏感（mAPMN/S）的前列腺癌成人患者（既往称为转移性激素敏感性前列腺癌）。6/12/2026 FDA批准贝组替凡联合帕博利珠单抗用于肾细胞癌辅助治疗 2026年6月12日，美国食品药品监督管理局（FDA）批准贝组替凡（Welireg，默克公司）联合帕博利珠单抗（Keytruda，默克公司），或联合帕博利珠单抗与berahyaluronidase alfa-pmph（Keytruda Qlex，默克公司），用于成人伴透明细胞成分的肾细胞癌（ccRCC）患者在肾切除术后，或肾切除术及转移灶切除术后具有中高危或高危复发风险的辅助治疗。6/12/2026 FDA批准度伐利尤单抗联合卡介苗用于高危非肌层浸润性膀胱癌 2026年5月28日，美国食品药品监督管理局（FDA）批准度伐利尤单抗（Imfinzi，阿斯利康）联合卡介苗（BCG），用于治疗未接受过BCG的高危非肌层浸润性膀胱癌（NMIBC）成人患者。5/28/2026 FDA批准pivekimab sunirine-pvzy用于母细胞性浆细胞样树突状细胞肿瘤——一种超罕见血液系统恶性肿瘤。2026年5月27日，美国食品药品监督管理局（FDA）批准pivekimab sunirine-pvzy（Decnupaz，AbbVie公司），一种靶向CD123的抗体与烷化剂偶联物，用于成人母细胞性浆细胞样树突状细胞肿瘤（BPDCN）。2026年5月27日 FDA批准datopotamab deruxtecan-dlnk用于不可切除或转移性三阴性乳腺癌。2026年5月22日，美国食品药品监督管理局批准datopotamab deruxtecan-dlnk（Datroway，Daiichi Sankyo公司）用于不适合PD-1/PD-L1抑制剂治疗的不可切除或转移性三阴性乳腺癌（TNBC）成人患者。2026年5月22日 FDA批准法姆-曲妥珠单抗 deruxtecan-nxki 用于HER2阳性早期乳腺癌的两项独立适应证2026年5月15日，美国食品药品监督管理局（FDA）批准法姆-曲妥珠单抗 deruxtecan-nxki（T-DXd，Enhertu，第一三共株式会社）用于成人HER2阳性早期乳腺癌的两项独立适应证。第一项适应证为T-DXd继以紫杉类、曲妥珠单抗和帕妥珠单抗（THP），用于经FDA授权检测确定的HER2阳性（IHC 3+或ISH+）II期或III期乳腺癌成人患者的新辅助治疗。第二项适应证为T-DXd用于HER2阳性（IHC 3+或ISH+）乳腺癌成人患者的辅助治疗，这些患者在接受曲妥珠单抗（联合或不联合帕妥珠单抗）和以紫杉类为基础的新辅助治疗后仍有残留浸润性疾病。2026年5月15日 FDA批准阿替利珠单抗用于辅助治疗
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Oncology (Cancer)/Hematologic Malignancies Approval Notifications 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 FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. WebpageDescriptionDate FDA grants accelerated approval to amivantamab and hyaluronidase-lpuj for recurrent or metastatic head and neck squamous cell carcinomaOn November 5, 2026, the Food and Drug Administration granted accelerated approval to amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for adults 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 antibody. Amivantamab and hyaluronidase-lpuj is not indicated for patients with oropharyngeal squamous cell carcinoma (OPSCC) that is HPV-associated.11/5/2026 FDA approves talazoparib with enzalutamide for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with HRR gene mutationsOn October 26, 2026, the Food and Drug Administration (FDA) approved talazoparib (Talzenna, Pfizer Inc.) in combination with enzalutamide for the treatment of adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with homologous recombination repair (HRR) gene mutations, as detected by an FDA-authorized test.10/26/2026 FDA grants traditional approval for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indicationOn October 16, 2026, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥13 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.10/22/2026 FDA grants accelerated approval to dostarlimab for locally advanced rectal cancerOn October 19, 2026, the Food and Drug Administration granted accelerated approval to dostarlimab (Jemperli, GSK) for adults with Stage II/III locally advanced rectal cancer (LARC) that is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-authorized test for solid tumors.10/19/2026 FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancerOn October 14, 2026, the Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This revises the prior indication for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors to include patients with high-grade papillary-only tumors.10/14/2026 FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancerOn October 8, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer. The FDA also approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients 12 years of age and older who weigh 40 kg or greater with Stage III dMMR colon cancer.10/8/2026 FDA approves tucatinib with trastuzumab and pertuzumab for the maintenance treatment of HER2-positive breast cancerOn October 7, 2026, the Food and Drug Administration approved tucatinib (Tukysa, Seagen Inc., a subsidiary of Pfizer) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment.10/7/2026 FDA approves pirtobrutinib for previously untreated chronic lymphocytic leukemia or small lymphocytic lymphomaOn October 2, 2026, the Food and Drug Administration approved pirtobrutinib (Jaypirca, Eli Lilly and Company) for adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion.10/2/2026 FDA approves belzutifan in combination with lenvatinib for advanced renal cell carcinoma with a clear cell componentOn September 24, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with lenvatinib (Lenvima, Eisai Inc.) for adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. 9/24/2026 FDA approves lirafugratinib for previously treated, unresectable, locally advanced or metastatic cholangiocarcinomaOn September 23, 2026, the Food and Drug Administration approved lirafugratinib (Lyrfigtu, Elevar Therapeutics, Inc.), a kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement.9/23/2026 FDA approves imlunestrant in combination with abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancerOn September 18, 2026, the Food and Drug Administration approved imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio), for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. Inluriyo and Verzenio are manufactured by Eli Lilly and Company.9/18/2026 FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancerOn September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for 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 test.9/9/2026 FDA grants accelerated approval to camizestrant with a CDK4/6 inhibitor for ESR1-Mutated HR-positive, HER2-negative locally advanced or metastatic breast cancerOn September 4, 2026, the Food and Drug Administration granted accelerated approval to camizestrant (Etcamah, AstraZeneca), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test. 9/4/2026 FDA approves daraxonrasib for metastatic pancreatic adenocarcinomaOn August 26, 2026, the Food and Drug Administration approved daraxonrasib (RASONQUE, Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.8/26/2026 FDA approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinomaOn August 25, 2026, the Food and Drug Administration approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals) in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr (Tevimbra, BeOne Medicines USA, Inc.), as first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test, and in combination with fluoropyrimidine-, and platinum-containing chemotherapy, as first-line treatment for adults with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test.: dolutegravir 8/25/2026 FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myelomaOn August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.8/13/2026 FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanomaOn August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.8/6/2026 FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancerOn July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or-sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer).7/31/2026 FDA approves zidesamtinib for ROS1-positive non-small cell lung cancerOn July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).7/22/2026 FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancerOn July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.7/14/2026 FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumorsOn July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.7/14/2026 FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancerOn July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who are cisplatin-ineligible to all patients with MIBC who are candidates for cystectomy.7/10/2026 FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indicationsOn July 9, 2026, the Food and Drug Administration approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications.7/09/2026 FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignanciesOn June 30, 2026, the Food and Drug Administration approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq (Tregzi, Orca Bio) for use in matched donor hematopoietic stem cell transplantation (HSCT) with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGHVD)-free survival, in the treatment of adults with hematological malignancies.6/30/2026 FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancerOn June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC). 6/24/2026 FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancerOn June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.6/24/2026 FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancerOn June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.6/12/2026 FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinomaOn June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.6/12/2026 FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancerOn May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).5/28/2026 FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancyOn May 27, 2026, the Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).5/27/2026 FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancerOn May 22, 2026, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.5/22/2026 FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancerOn May 15, 2026, the Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for T-DXd for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane-based treatment.5/15/2026 FDA approves atezolizumab for adjuvant treatment of
摘要 待译
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.