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

FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

FDA批准摘要:尼拉帕尼联合醋酸阿比特龙固定剂量组合用于治疗BRCA突变转移性去势抵抗性前列腺癌

Maguire, William F; Chi, Dow-Chung; Agrawal, Sundeep; Joeng, Hee-Koung; Kim-McOlash, Sarah; Manheng, Wimolnut; Bulatao, Ilynn; Sanchez-Solana, Beatriz; Pathak, Anand; Lee, Alice; Han, Yu; Ricks, Tiffany K; Hamed, Salaheldin S; Fiero, Mallorie H; Pierce, William F; Kalavar, Shyam; Ghosh, Soma; Leighton, John K; Tang, Shenghui; Amiri-Kordestani, Laleh; Kluetz, Paul G; Suzman, Daniel L

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: Nadofaragene Firadenovec-vncg for Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer

FDA批准摘要:Nadofaragene Firadenovec-vncg用于治疗卡介苗无效的非肌层浸润性膀胱癌

Colbert, Laronna; Jia, Yuxia; Sharma, Anurag; Hu, Jiang; Xu, Zhenzhen; Suzman, Daniel L; Das, Asha; Bross, Peter; Kluetz, Paul G; Fashoyin-Aje, Lola A

Adoption of Decentralized Trial Elements in Cancer Clinical Trials Supporting FDA Approvals during COVID-19

新冠疫情期间,癌症临床试验中采用分散式试验要素支持FDA批准

Patel, Timil H; Corneli, Amy; Balcazar, Pamela; Lipset, Craig; Calvert, Sara B; Mervin-Blake, Sabrena; Nalawade, Vinit; Kluetz, Paul G

FDA Approval Summary: Afamitresgene Autoleucel for Adults with HLA-Restricted, MAGE-A4-Positive Unresectable or Metastatic Synovial Sarcoma after Prior Chemotherapy

FDA批准摘要:Afamitresgene Autoleucel用于治疗既往接受过化疗的HLA限制性、MAGE-A4阳性不可切除或转移性滑膜肉瘤成人患者

Barnett, Katherine K; Johnson, Abigail R; Das, Asha; Lee, Ching-Hsien J; Wang, Cong; Wang, Xiaofei; Cho, Elin S; Kluetz, Paul G; Fashoyin-Aje, Lola A

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

Feasibility of structuring electronic health record data to facilitate real-world data research: ICAREdata methods applied to multicenter cancer clinical trials

构建电子健康记录数据以促进真实世界数据研究的可行性:ICAREdata 方法在多中心癌症临床试验中的应用

George, Suzanne; Campbell, Nancy; Hillman, Shauna L; Harlos, Elizabeth S; Stein, David W J; Chan, Miranda Y; Chow, Selina L; Elrahi, Cassandra L; Quina, Andre C; Kokolus, Maeve C; Casagni, Michelle D; Weiss, Matthias; Anderson, Daniel M; Stadler, Walter M; Hoff, Olivia C; Rivera, Donna R; Kluetz, Paul G; Mandrekar, Sumithra J; Piantadosi, Steven

The Food and Drug Administration pooled analysis of overall survival according to depth of response in frontline advanced immune-oncology renal cell carcinoma trials

美国食品药品监督管理局对一线晚期免疫肿瘤治疗肾细胞癌的试验中,根据反应深度对总生存期进行了汇总分析。

Chang, Elaine; Gittleman, Haley; Song, Chi; Bloomquist, Erik; Fernandes, Laura; Weinstock, Chana; Agrawal, Sundeep; Gormley, Nicole; Tang, Shenghui; Suzman, Daniel L; Amiri-Kordestani, Laleh; Pazdur, Richard; Kluetz, Paul G; McDermott, David F; Regan, Meredith M; Rini, Brian I