日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

FDA Approval Summary: Pembrolizumab for the Treatment of HER2-Positive Gastric Cancer

FDA批准摘要:帕博利珠单抗用于治疗HER2阳性胃癌

Casak, Sandra J; Zhang, Yiming; Song, Chi; Mishra-Kalyani, Pallavi S; Tang, Shenghui; Auth, Doris; de Claro, R Angelo; Pazdur, Richard; Lemery, Steven J

FDA Approval Summary: Tarlatamab for the Treatment of Extensive-Stage Small Cell Lung Cancer

FDA批准摘要:Tarlatamab用于治疗广泛期小细胞肺癌

Liu, Yufan; Nashed, Jeannette; Barone, Amy K; Yuan, Mengdie; Amatya, Anup K; Xiang, Yue; Zhao, Hong; Bi, Youwei; Pegues, Melissa A; Miller, Claudia P; Lane, Ashley R; Mixter, Bronwyn D; Tang, Shenghui; Pazdur, Richard; de Claro, R Angelo; Larkins, Erin

US Food and Drug Administration Approval Summary: Imetelstat for Selected Patients With Low- to Intermediate-1 Risk Myelodysplastic Syndromes With Transfusion-Dependent Anemia

美国食品药品监督管理局批准摘要:伊美替司他用于治疗部分低危至中危-1型骨髓增生异常综合征伴输血依赖性贫血患者

Kim, Nina; Pulte, E Dianne; Ehrlich, Lori A; Ionan, Alexei C; Haupert, Spencer; Vallejo, Jonathon; Green, Francis; Zheng, Nan; Wang, Yun; Liu, Jiang; Blanco, Javier G; Dorff, Sarah E; Booth, Brian; Choe, Moran; Gehrke, Brenda; Bhatnagar, Vishal; Theoret, Marc; Pazdur, Richard; De Claro, R Angelo; Norsworthy, Kelly J

FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase 1 Mutation

FDA批准摘要:奥鲁西地尼用于治疗伴有异柠檬酸脱氢酶1突变的复发或难治性急性髓系白血病成人患者

Woods, Ashley C; Norsworthy, Kelly J; Choe, Moran; Gehrke, Brenda J; Chen, Haiyan; Vallejo, Jonathon; Pan, Lili; Jiang, Xiling; Li, Hongshan; Kraft, Jeffrey; Liu, Jiang; Charlab, Rosane; Okusanya, Olanrewaju O; Booth, Brian; Pazdur, Richard; Theoret, Marc R; Angelo de Claro, R

FDA Approval Summary: Nogapendekin Alfa Inbakicept-pmln with BCG for BCG-Unresponsive Carcinoma In Situ

FDA批准摘要:诺加潘地金α(Nogapendekin Alfa)联合卡介苗(BCG)治疗对卡介苗无反应的原位癌

Heiss, Brian L; Chang, Elaine; Joeng, Hee-Koung; Fiero, Mallorie H; Wang, Lingshan; Hamed, Salaheldin S; Chiu, Haw-Jyh; Ricks, Tiffany K; Koh, Eun Hee; Dellibovi-Ragheb, Teegan A; Wang, Min; Lee, Christal; Pierce, William F; Leighton, John K; Rahman, Nam Atiqur; Tang, Shenghui; Pazdur, Richard; Amiri-Kordestani, Laleh; Kluetz, Paul G; Suzman, Daniel L

FDA Approval Summary: Datopotamab Deruxtecan-dlnk for Treatment of Patients with Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer

FDA批准摘要:Datopotamab Deruxtecan-dlnk用于治疗不可切除或转移性、HR阳性、HER2阴性乳腺癌患者

Royce, Melanie; Shah, Mirat; Zhang, Lijun; Cheng, Joyce; Bonner, Mary Kate; Pegues, Melissa; Miller, Claudia P; Leu, Lily; Price, Lauren S L; Qiu, Junshan; Yu, Jingyu; Truong, Tien M; Dorff, Sarah E; Yang, Yuching; Zhang, Nailing; Gutierrez-Lugo, Maria; Ricks, Tiffany K; Pierce, William F; Luo, Zhongjun; Kappel, Dana; Goldberg, Kirsten B; Shord, Stacy S; Tang, Shenghui; Bhatnagar, Vishal; Pazdur, Richard; Kluetz, Paul G; Amiri-Kordestani, Laleh

FDA Approval Summary: Vorasidenib for IDH-Mutant Grade 2 Astrocytoma or Oligodendroglioma Following Surgery

FDA批准摘要:Vorasidenib用于IDH突变型2级星形细胞瘤或少突胶质细胞瘤术后治疗

Barbato, Michael I; Barone, Amy K; Aungst, Stephanie L; Miller, Claudia P; Ananthula, Suryatheja; Bi, Youwei; Yang, Yuching; Li, Xiaoxue; Xiong, Ye; Fan, Jianghong; Dorff, Sarah E; Zhao, Hong; Zhou, Hua; Pradhan, Shan; Scepura, Barbara; Sinha, Arup K; Stephenson, Maritsa; Bhatnagar, Vishal; Saber, Haleh; Rahman, Nam Atiqur; Tang, Shenghui; Pazdur, Richard; Kluetz, Paul G; Larkins, Erin; Drezner, Nicole

FDA Approval Summary: Tovorafenib for Relapsed or Refractory BRAF-Altered Pediatric Low-Grade Glioma

FDA批准摘要:托沃拉非尼用于治疗复发或难治性BRAF突变型儿童低级别胶质瘤

Singh, Sonia; Bradford, Diana; Chatterjee, Somak; Li, Xiaoxue; Aungst, Stephanie L; Skinner, Amy M; Miller, Claudia P; Kim-McOlash, Sarah; Fourie Zirkelbach, Jeanne; Xiong, Ye; Bi, Youwei; Wang, Ying-Hong; Yang, Yuching; Sun, Jielin; Kraft, Jeffrey; Charlab, Rosane; Shord, Stacy S; Tang, Shenghui; Scepura, Barbara; Bulatao, Ilynn; Udoka, Opeyemi; Saber, Haleh; Rahman, Nam Atiqur; Pazdur, Richard; Singh, Harpreet; Donoghue, Martha; Drezner, Nicole

FDA Approval Summary: Abatacept for the Prophylaxis of Acute GVHD

FDA批准摘要:阿巴西普用于预防急性GVHD

Norsworthy, Kelly J; Rivera, Donna R; Wynne, Joseph; Zhao, Jian; Konicki, Robyn; Kuzucan, Aida; Vallejo, Jonathon; Leong, Ruby; Okusanya, Olanrewaju O; Booth, Brian; Kluetz, Paul G; Pazdur, Richard; de Claro, R Angelo

FDA Approval Summary: Axatilimab for Adult and Pediatric Patients Weighing at Least 40 Kilograms with Chronic GVHD after Two Prior Lines of Systemic Therapy

FDA批准摘要:阿沙利单抗适用于体重至少40公斤且既往接受过两线全身治疗后出现慢性移植物抗宿主病(GVHD)的成人和儿童患者

Le, Robert Q; Godder, Kamar; Wang, Jingyan; Collazo, Justin S; Konicki, Robyn; Choe, Moran; Feng, Monica; Przepiorka, Donna; Vallejo, Jonathon; Shah, Ankit; Liu, Jiang; Gehrke, Brenda J; Wilson, Willie; Siegel, Andrea; Wu, Yun; Kuo, Charles Yuan-Chia; Ray, Melissa; Pazdur, Richard; Theoret, Marc R; de Claro, R Angelo