Not logged in The Food and Drug Administration pooled analysis of overall survival according to depth of response in frontline advanced immune-oncology renal cell carcinoma trials 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 Share Save
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FDA Approval Summary: Polatuzumab Vedotin in the First-Line Treatment of Select Large B-Cell Lymphomas Yazdy, Maryam Sarraf; Kasamon, Yvette L.; Gu, Wenjuan; Rodriguez, Lisa R.; Jin, Susan; Bhatnagar, Vishal; Richardson, Nicholas C.; Theoret, Marc R.; Pazdur, Richard; Gormley, Nicole J. Share Save
Advancing Global Health Equity in Oncology Clinical Trial Access Adewole, Tolulope; Albrecht, Bjorn; Beg, Shaalan; Brawley, Otis; Chang, I-Fen; Daly, Bobby; de Claro, Angelo; Dent, Jennifer; Dickler, Maura; Ene-Obong, Abasi; Fashoyin-Aje, Lola; Finnegan, Justin; Galbraith, Susan; Gospodarowicz, Mary; Gralow, Julie; Haddad, Tufia; Kalidas, Chitkala; Katz, Artur; Kaucic, Karen; Keane, Harriet; Lanasa, Mark; Legos, Jeff; Li, Bob T.; Mills, Jennifer; Oelrich, Stefan; Olopade, Stefan; Palma, John; Pazdur, Richard; Pilarski, Piotr; Qian, Jing; Rudd, Kevin; Shokrpour, Sepideh; Tendler, Craig; Wilson, Matt; Smart, Victoria W.; Wu, Yi-Long; Yan, James; Zhang, Lianshan; Li, Diya; Shen, Johanna; Silverstein, Amy; Abou-Alfa, Ghassan; Anderson, Shelly; Beyrer, Patrick; Carnival, Danielle; Clarke, Stephen; Conneran, Terri; Deangelis, Lisa M.; Diakos, Connie; Diaz, Luis; dos Anjos, Carlos Henrique; Drebin, Jeffrey A.; Eisenmen, Debra; Flannery, Russell; Fredrickson, David; Isbell, James M.; Jones, David R.; Joseph, Adedayo; Kennedy, Caroline; Kingham, T. Peter; Lee, Adrian; Lee, Nancy Y.; Leigh, Lillian; Li, Zhi-Zhong; Liu, An-Wen; Liu, Dazhi; Liu, Si-Yang; Maggie Liu, Si-Yang; Makker, Vicky; Mallafre-Larrosa, Meritxell; Mcbride, Sean; Mestres, Isabel; Mondaca, Sebastian; Nigro, Paulo; Norton, Larry; Oyler, John V.; Pavlakis, Nick; Powell, Simon; Robinson, Bruce; Qin, Yi; Razavi, Pedram; Reis-Filho, Jorge; Rocco, Gaetano; Rudin, Charles M.; Schell, Orville; Scher, Howard I.; Schrag, Deborah; Simon, Greg; Smith, Dorrance; Speece, Morgan; Tu, Hai-Yan; Umar-Sadiq, Aminu; Wang, Bu-Hai; Wheeler, Helen; Xu, Chong-Rui; Yan, Li-Xu; Yang, Fan; Yoon, Byeong; Young, Catharine; Zhang, Jia-Tao; Zhou, Qing Share Save
RE: Is it time to reconsider the role of upfront cytoreductive nephrectomy in metastatic renal cell carcinoma? Fallah, Jaleh; Gittleman, Haley; Weinstock, Chana; Chang, Elaine; Agrawal, Sundeep; Tang, Shenghui; Pazdur, Richard; Kluetz, Paul G.; Suzman, Daniel L.; Amiri-Kordestani, Laleh Share Save
Reflections and Roadmaps: Career Development beyond the FDA-AACR Oncology Educational Fellowship Patel, Timil; Chen, Chris; Al Hadidi, Samer; Kadry, Yasmin; Sridhara, Rajeshwari; Purcell, Erin; Wisch, Laura; Retzlaff, Jon; Foti, Margaret; Pazdur, Richard; Kluetz, Paul; Gao, Jennifer Share Save
Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a US Food and Drug Administration pooled analysis Fallah, Jaleh; Gittleman, Haley; Weinstock, Chana; Chang, Elaine; Agrawal, Sundeep; Tang, Shenghui; Pazdur, Richard; Kluetz, Paul G.; Suzman, Daniel L.; Amiri-Kordestani, Laleh Share Save
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Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development Donaldson, Joshua M.; Seddiq, Marjilla; Fusco, Michael J.; Singla, Shyamli; Pamuk, Gulsum E.; Lee-Alonso, Rosa J.; Mixter, Bronwyn D.; Goldberg, Kirsten B.; Amiri-Kordestani, Laleh; De Claro, R. Angelo; Drezner, Nicole; Gormley, Nicole J.; Kanapuru, Bindu; Lemery, Steven J.; Fashoyin-Aje, Lola A.; Richardson, Nicholas C.; Singh, Harpreet; Suzman, Daniel L.; Theoret, Marc R.; Kluetz, Paul G.; Pazdur, Richard Share Save
FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation Woods, Ashley; Norsworthy, Kelly J.; Wang, Xin; Vallejo, Jonathon; Chow, Edwin Chiu Yuen; Li, Ruo-Jing; Sun, Jielin; Charlab, Rosane; Jiang, Xiling; Pazdur, Richard; Theoret, Marc R.; de Claro, R. Angelo Share Save
A US Food and Drug Administration-pooled Analysis of Frontline Combination Treatment Survival Benefits by Risk Groups in Metastatic Renal Cell Carcinoma Lee, Daniel; Gittleman, Haley; Weinstock, Chana; Suzman, Daniel; Bloomquist, Erik; Agrawal, Sundeep; Brave, Michael; Brewer, Jamie; Fallah, Jaleh; Singh, Harpreet; Tang, Shenghui; Ibrahim, Amna; Pazdur, Richard; Beaver, Julia A.; Amiri-Kordestani, Laleh Share Save
FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma Patel, Timil H.; Brewer, Jamie R.; Fan, Jiaxin; Cheng, Joyce; Shen, Yuan-Li; Xiang, Yue; Zhao, Hong; Lemery, Steven J.; Pazdur, Richard; Kluetz, Paul G.; Fashoyin-Aje, Lola A. Share Save
Trends in the approval of cancer therapies by the FDA in the twenty-first century Scott, Emma C.; Baines, Andrea C.; Gong, Yutao; Moore Jr, Rodney; Pamuk, Gulsum E.; Saber, Haleh; Subedee, Ashim; Thompson, Matthew D.; Xiao, Wenming; Pazdur, Richard; Rao, V. Ashutosh; Schneider, Julie; Beaver, Julia A. Share Save
FDA ANALYSIS OF EXPANDED ACCESS USE IN PEDIATRIC PATIENTS WITH CNS TUMORS FROM 2015 TO 2020 Duke, Elizabeth; Kormanik, Natasha; Barone, Amy; Chan, Mitchell; Antony, Ramya; Drezner, Nicole; Kluetz, Paul; Kim, Tamy; Singh, Harpreet; Pazdur, Richard; Donoghue, Martha Share Save
Association between antibiotics and adverse oncological outcomes in patients receiving targeted or immune-based therapy for hepatocellular carcinoma Pinato, David J.; Li, Xiaoxue; Mishra-Kalyani, Pallavi; D'Alessio, Antonio; Fulgenzi, Claudia A. M.; Scheiner, Bernhard; Pinter, Matthias; Wei, Guo; Schneider, Julie; Rivera, Donna R.; Pazdur, Richard; Theoret, Marc R.; Casak, Sandra; Lemery, Steven; Fashoyin-Aje, Lola; Cortellini, Alessio; Pelosof, Lorraine Share Save
FDA Approval Summary: Atezolizumab as Adjuvant Treatment following Surgical Resection and Platinum-Based Chemotherapy for Stage II to IIIA NSCLC Mathieu, Luckson N.; Larkins, Erin; Sinha, Arup K.; Mishra-Kalyani, Pallavi S.; Jafri, Samina; Kalavar, Shyam; Ghosh, Soma; Goldberg, Kirsten B.; Pazdur, Richard; Beaver, Julia A.; Singh, Harpreet Share Save
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FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor 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. Share Save
Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development Duke, Elizabeth S.; Fusco, Michael J.; DeMoss, Patrick; Dilawari, Asma; Pamuk, Gulsum E.; Boehmer, Jessica; Mixter, Bronwyn; Goldberg, Kirsten B.; Kluetz, Paul; Pazdur, Richard Share Save
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