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

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: 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: Alpelisib for PIK3CA-Related Overgrowth Spectrum

FDA批准摘要:Alpelisib用于治疗PIK3CA相关过度生长谱

Singh, Sonia; Bradford, Diana; Li, Xiaoxue; Mishra-Kalyani, Pallavi S; Shen, Yuan-Li; Wang, Lingshan; Zhao, Hong; Xiong, Ye; Liu, Jiang; Charlab, Rosane; Kraft, Jeffrey; Khasar, Sachia; Miller, Claudia P; Rivera, Donna R; Kluetz, Paul G; Pazdur, Richard; Beaver, Julia A; Singh, Harpreet; Donoghue, Martha

FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation

FDA批准摘要:伊沃西尼联合阿扎胞苷治疗新诊断的伴有IDH1突变的急性髓系白血病患者

Woods, Ashley; Norsworthy, Kelly J; Wang, Xin; Vallejo, Jonathon; Chiu Yuen Chow, Edwin; Li, Ruo-Jing; Sun, Jielin; Charlab, Rosane; Jiang, Xiling; Pazdur, Richard; Theoret, Marc R; de Claro, R Angelo

FDA Approval Summary: Asciminib for Ph+ CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the T315I Mutation

FDA批准摘要:Asciminib用于治疗接受过两种或两种以上酪氨酸激酶抑制剂治疗的慢性期Ph+ CML以及携带T315I突变的CML

Pamuk, Gulsum E; Chow, Edwin C Y; Ionan, Alexei C; Chen, Haiyan; Lee, Shwu-Luan; Hsu, Vicky; Grimstein, Manuela; Zheng, Nan; Sun, Jielin; Charlab, Rosane; Gehrke, Brenda J; Vallejo, Jonathon; Ehrlich, Lori A; de Claro, R Angelo; Theoret, Marc R

FDA Approval Summary: Capecitabine Labeling Update under Project Renewal

FDA批准摘要:卡培他滨标签更新(项目续期)

Agrawal, Sundeep; Lee, Clara; Pierce, William F; Everhart, Elizabeth; King-Ducre, Adriene; Royce, Melanie; Osgood, Christy L; Amiri-Kordestani, Laleh; Chiu, Haw-Jyh; Ricks, Tiffany K; Pan, Lili; Fourie Zirkelbach, Jeanne; Charlab, Rosane; Pacanowski, Michael; Kim, Tamy; Pazdur, Richard; Kluetz, Paul G; Gao, Jennifer J

Pediatric Cancer Drug Development: Leveraging Insights in Cancer Biology and the Evolving Regulatory Landscape to Address Challenges and Guide Further Progress

儿童癌症药物研发:利用对癌症生物学和不断变化的监管环境的深刻理解来应对挑战并指导未来的发展

Charlab, Rosane; Leong, Ruby; Shord, Stacy S; Reaman, Gregory H

FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement

FDA批准摘要:Pemigatinib用于治疗既往接受过治疗、无法切除的局部晚期或转移性胆管癌,伴有FGFR2融合或其他重排

Patel, Timil H; Marcus, Leigh; Horiba, M Naomi; Donoghue, Martha; Chatterjee, Somak; Mishra-Kalyani, Pallavi S; Schuck, Robert N; Li, Yangbing; Zhang, Xinyuan; Fourie Zirkelbach, Jeanne; Charlab, Rosane; Liu, Jiang; Yang, Yuching; Lemery, Steven J; Pazdur, Richard; Theoret, Marc R; Fashoyin-Aje, Lola A

FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor

FDA批准摘要:瑞普替尼用于治疗晚期胃肠道间质瘤

Kumar, Vaibhav; Doros, Leslie; Thompson, Margaret; Mushti, Sirisha L; Charlab, Rosane; Spehalski, Elizabeth I; Zhao, Hong; Thompson, Matthew D; Tang, Shenghui; Pazdur, Richard; Lemery, Steven J; Theoret, Marc R; Fashoyin-Aje, Lola A

FDA Approval Summary: Amivantamab for the Treatment of Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

FDA批准摘要:Amivantamab用于治疗携带EGFR 20号外显子插入突变的非小细胞肺癌患者

Chon, Katie; Larkins, Erin; Chatterjee, Somak; Mishra-Kalyani, Pallavi S; Aungst, Stephanie; Wearne, Emily; Subramaniam, Sriram; Li, Yangbing; Liu, Jiang; Sun, Jielin; Charlab, Rosane; Zhao, Hong; Saritas-Yildirim, Banu; Bikkavilli, Rama Kamesh; Ghosh, Soma; Philip, Reena; Beaver, Julia A; Singh, Harpreet