FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors von Marcus, Leigh, Lemery, Steven J, Keegan, Patricia, Pazdur, Richard

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FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden-High Solid for Tumors von Marcus, Leigh, Fashoyin-Aje, Lola A., Donoghue, Martha, Yuan, Mengdie, Rodriguez, Lisa, Gallagher, Pamela S., Philip, Reena, Ghosh, Soma, Theoret, Marc R., Beaver, Julia A., Pazdur, Richard, Lemery, Steven J.

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FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine-Refractory Differentiated Thyroid Cancer von Nair, Abhilasha, Lemery, Steven J, Yang, Jun, Marathe, Anshu, Zhao, Liang, Zhao, Hong, Jiang, Xiaoping, He, Kun, Ladouceur, Gaetan, Mitra, Amit K, Zhou, Liang, Fox, Emily, Aungst, Stephanie, Helms, Whitney, Keegan, Patricia, Pazdur, Richard

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FDA Approval Summary: Ramucirumab for Gastric Cancer von 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

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FDA Approval Summary: TAS-102 von Marcus, Leigh, Lemery, Steven J, Khasar, Sachia, Wearne, Emily, Helms, Whitney S, Yuan, Weishi, He, Kun, Cao, Xianhua, Yu, Jingyu, Zhao, Hong, Wang, Yaning, Stephens, Olen, Englund, Erika, Agarwal, Rajiv, Keegan, Patricia, Pazdur, Richard

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FDA's Approval of the First  Biosimilar to Bevacizumab von 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

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FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma von 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.

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Tissue-Agnostic Drug Development: A new Path to Drug Approval von Thein, Kyaw Z., Lemery, Steven J., Kummar, Shivaani

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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 von 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.

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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 von 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

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FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer von 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

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

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FDA Approval Summary: Selpercatinib for the treatment of advanced RET fusion-positive solid tumors von Duke, Elizabeth S, Bradford, Diana, Marcovitz, Michelle, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Nguyen, Emily, Price, Lauren S L, Fourie Zirkelbach, Jeanne, Li, Yangbing, Bi, Youwei, Kraft, Jeffrey, Dorff, Sarah E, Scepura, Barbara, Stephenson, Maritsa, Ojofeitimi, Idara, Nair, Abhilasha, Han, Yu, Tezak, Zivana, Lemery, Steven J, Pazdur, Richard, Larkins, Erin, Singh, Harpreet

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FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements von 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

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FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor von 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

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FDA's Approach to Regulating Biosimilars von Lemery, Steven J, Ricci, M Stacey, Keegan, Patricia, McKee, Amy E, Pazdur, Richard

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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 von 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

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Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples von Amatya, Anup K., Fiero, Mallorie H., Bloomquist, Erik W., Sinha, Arup K., Lemery, Steven J., Singh, Harpreet, Ibrahim, Amna, Donoghue, Martha, Fashoyin-Aje, Lola A., de Claro, R. Angelo, Gormley, Nicole J., Amiri-Kordestani, Laleh, Sridhara, Rajeshwari, Theoret, Marc R., Kluetz, Paul G., Pazdur, Richard, Beaver, Julia A., Tang, Shenghui

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FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors von Duke, Elizabeth S, Bradford, Diana, Marcovitz, Michelle, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Nguyen, Emily, Price, Lauren S L, Fourie Zirkelbach, Jeanne, Li, Yangbing, Bi, Youwei, Kraft, Jeffrey, Dorff, Sarah E, Scepura, Barbara, Stephenson, Maritsa, Ojofeitimi, Idara, Nair, Abhilasha, Han, Yu, Tezak, Zivana, Lemery, Steven J, Pazdur, Richard, Larkins, Erin, Singh, Harpreet

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U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab von LEMERY, Steven J, ZHANG, Jenny, KEEGAN, Patricia, PAZDUR, Richard, ROTHMANN, Mark D, JUN YANG, EARP, Justin, HONG ZHAO, MCDOUGAL, Andrew, PILARO, Anne, CHIANG, Raymond, GOOTENBERG, Joseph E

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