FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma
Casak, Sandra J, Donoghue, Martha, Fashoyin-Aje, Lola, Jiang, Xiaoping, Rodriguez, Lisa, Shen, Yuan-Li, Xu, Yuan, Jiang, Xiling, Liu, Jiang, Zhao, Hong, Pierce, William F, Mehta, Shubhangi, Goldberg, Kirsten B, Theoret, Marc R, Kluetz, Paul G, Pazdur, Richard, Lemery, Steven J
Published in Clinical cancer research (01.04.2021)
Published in Clinical cancer research (01.04.2021)
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FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma
Casak, Sandra J, Marcus, Leigh, Fashoyin-Aje, Lola, Mushti, Sirisha L, Cheng, Joyce, Shen, Yuan-Li, Pierce, William F, Her, Leah, Goldberg, Kirsten B, Theoret, Marc R, Kluetz, Paul G, Pazdur, Richard, Lemery, Steven J
Published in Clinical cancer research (01.09.2021)
Published in Clinical cancer research (01.09.2021)
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FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation
Casak, Sandra J, Pradhan, Shan, Fashoyin-Aje, Lola A, Ren, Yi, Shen, Yuan-Li, Xu, Yuan, Chow, Edwin Chiu Yuen, Xiong, Ye, Zirklelbach, Jeanne Fourie, Liu, Jiang, Charlab, Rosane, Pierce, William F, Fesenko, Nataliya, Beaver, Julia A, Pazdur, Richard, Kluetz, Paul G, Lemery, Steven J
Published in Clinical cancer research (01.07.2022)
Published in Clinical cancer research (01.07.2022)
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FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer
Casak, Sandra J, Horiba, M Naomi, Yuan, Mengdie, Cheng, Joyce, Lemery, Steven J, Shen, Yuan Li, Fu, Wentao, Moore, Jason N, Li, Yangbing, Bi, Youwei, Auth, Doris, Fesenko, Nataliya, Kluetz, Paul G, Pazdur, Richard, Fashoyin-Aje, Lola A
Published in Clinical cancer research (01.11.2023)
Published in Clinical cancer research (01.11.2023)
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FDA Approval Summary: Ramucirumab for Gastric Cancer
Casak, Sandra J, Fashoyin-Aje, Ibilola, Lemery, Steven J, Zhang, Lillian, Jin, Runyan, Li, Hongshan, Zhao, Liang, Zhao, Hong, Zhang, Hui, Chen, Huanyu, He, Kun, Dougherty, Michele, Novak, Rachel, Kennett, Sarah, Khasar, Sachia, Helms, Whitney, Keegan, Patricia, Pazdur, Richard
Published in Clinical cancer research (01.08.2015)
Published in Clinical cancer research (01.08.2015)
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FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint Inhibitors for the Treatment of Biliary Tract Cancer
Casak, Sandra J, Kumar, Vaibhav, Song, Chi, Yuan, Mengdie, Amatya, Anup K, Cheng, Joyce, Mishra-Kalyani, Pallavi S, Tang, Shenghui, Lemery, Steven J, Auth, Doris, Davis, Gina, Kluetz, Paul G, Pazdur, Richard, Fashoyin-Aje, Lola A
Published in Clinical cancer research (15.08.2024)
Published in Clinical cancer research (15.08.2024)
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FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements
Gandhy, Shruti U, Casak, Sandra J, Mushti, Sirisha L, Cheng, Joyce, Subramaniam, Sriram, Zhao, Hong, Zhao, Miao, Bi, Youwei, Liu, Guansheng, Fan, Jianghong, Adeniyi, Oluseyi, Charlab, Rosane, Kufrin, Dubravka, Thompson, Matthew D, Jarrell, Kristin, Auth, Doris, Lemery, Steven J, Pazdur, Richard, Kluetz, Paul G, Fashoyin-Aje, Lola A
Published in Clinical cancer research (13.10.2023)
Published in Clinical cancer research (13.10.2023)
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Journal Article
FDA's Approval of the First Biosimilar to Bevacizumab
Casak, Sandra J, Lemery, Steven J, Chung, Jee, Fuchs, Chana, Schrieber, Sarah J, Chow, Edwin C Y, Yuan, Weishi, Rodriguez, Lisa, Gwise, Thomas, Rowzee, Anne, Lim, Sue, Keegan, Patricia, McKee, Amy E, Pazdur, Richard
Published in Clinical cancer research (15.09.2018)
Published in Clinical cancer research (15.09.2018)
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FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease
Horiba, M Naomi, Casak, Sandra J, Mishra-Kalyani, Pallavi S, Roy, Pourab, Beaver, Julia A, Pazdur, Richard, Kluetz, Paul G, Lemery, Steven J, Fashoyin-Aje, Lola A
Published in Clinical cancer research (15.12.2022)
Published in Clinical cancer research (15.12.2022)
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Journal Article
FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer
Fusco, Michael J, Casak, Sandra J, Mushti, Sirisha L, Cheng, Joyce, Christmas, Brian J, Thompson, Matthew D, Fu, Wentao, Wang, Hezhen, Yoon, Miyoung, Yang, Yuching, Moore, Jason N, Bi, Youwei, Nan, Yang, Long, Craig E, Auth, Doris, Rahman, Nam A, Tang, Shenghui, Pazdur, Richard, Fashoyin-Aje, Lola A, Kluetz, Paul G, Lemery, Steven J
Published in Clinical cancer research (01.08.2024)
Published in Clinical cancer research (01.08.2024)
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Journal Article
The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative
Jarow, Jonathan P, Casak, Sandra, Chuk, Meredith, Ehrlich, Lori A, Khozin, Sean
Published in Clinical cancer research (01.05.2016)
Published in Clinical cancer research (01.05.2016)
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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
Published in JHEP reports (01.06.2023)
Published in JHEP reports (01.06.2023)
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U.S. Food and Drug Administration Approval: Rituximab in Combination with Fludarabine and Cyclophosphamide for the Treatment of Patients with Chronic Lymphocytic Leukemia
Casak, Sandra J., Lemery, Steven J., Shen, Yuan Li, Rothmann, Mark D., Khandelwal, Aakanksha, Zhao, Hong, Davis, Gina, Jarral, Vaishali, Keegan, Patricia, Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.01.2011)
Published in The oncologist (Dayton, Ohio) (01.01.2011)
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FDA analysis of grade 3-4 safety events
Smit, Marie-Anne Damiette, Casak, Sandra J., Lemery, Steven, Keegan, Patricia, McKee, Amy E.
Published in Journal of clinical oncology (20.05.2017)
Published in Journal of clinical oncology (20.05.2017)
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Experience with chemoreduction and focal therapy for intraocular retinoblastoma in a developing country
Chantada, Guillermo L., Fandiño, Adriana C., Raslawski, Elsa C., Manzitti, Julio, de Dávila, Maria T.G., Casak, Sandra J., Scopinaro, Marcelo J., Schvartzman, Enrique
Published in Pediatric blood & cancer (01.05.2005)
Published in Pediatric blood & cancer (01.05.2005)
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FDA analysis of treatment efficacy based on etiology of hepatocellular carcinoma
Saung, May Tun, Fan, Jiaxin, Cheng, Joyce, Shen, Yuan-Li, Casak, Sandra J., Lemery, Steven, Fashoyin-Aje, Lola A.
Published in Journal of clinical oncology (01.06.2023)
Published in Journal of clinical oncology (01.06.2023)
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Journal Article
Geographical and baseline clinical characteristics of participants enrolled in hepatocellular carcinoma (HCC) trials: Analysis of US FDA approvals
Horiba, M. Naomi, Gandhy, Shruti U., Casak, Sandra J., Lemery, Steven, Kluetz, Paul, Pazdur, Richard, Fashoyin-Aje, Lola A.
Published in Journal of clinical oncology (01.06.2023)
Published in Journal of clinical oncology (01.06.2023)
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Journal Article
FDA Approval Summary: Nivolumab Plus Ipilimumab for the Treatment of Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib
Saung, May Tun, Pelosof, Lorraine, Casak, Sandra, Donoghue, Martha, Lemery, Steven, Yuan, Mengdie, Rodriguez, Lisa, Schotland, Peter, Chuk, Meredith, Davis, Gina, Goldberg, Kirsten B., Theoret, Marc R., Pazdur, Richard, Fashoyin‐Aje, Lola
Published in The oncologist (Dayton, Ohio) (01.09.2021)
Published in The oncologist (Dayton, Ohio) (01.09.2021)
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Activity of topotecan in retinoblastoma
Chantada, Guillermo L., Fandiñ, Adriana C., Casak, Sandra J., Mato, Gabriel, Manzitti, Julio, Schvartzman, Enrique
Published in Ophthalmic genetics (01.03.2004)
Published in Ophthalmic genetics (01.03.2004)
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