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Sandra J. Casak
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Journal Articles

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

Sandra J. Casak, M. Naomi Horiba, Mengdie Yuan, Joyce Cheng, Steven J. Lemery, Yuan Li Shen, Wentao Fu, Jason N. Moore, Yangbing Li, Youwei Bi, Doris Auth, Nataliya Fesenko, Paul G. Kluetz, Richard Pazdur, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (21): 4326–4330.
https://doi.org/10.1158/1078-0432.CCR-23-1041
Published: 01 November 2023
View article titled, FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, <em>HER2</em>-Positive <em>RAS</em> Wild-Type Colorectal Cancer
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Journal Articles

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

Shruti U. Gandhy, Sandra J. Casak, Sirisha L. Mushti, Joyce Cheng, Sriram Subramaniam, Hong Zhao, Miao Zhao, Youwei Bi, Guansheng Liu, Jianghong Fan, Oluseyi Adeniyi, Rosane Charlab, Dubravka Kufrin, Matthew D. Thompson, Kristin Jarrell, Doris Auth, Steven J. Lemery, Richard Pazdur, Paul G. Kluetz, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (20): 4027–4031.
https://doi.org/10.1158/1078-0432.CCR-23-1042
Published: 13 October 2023
View article titled, FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements
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Journal Articles

FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease

M. Naomi Horiba, Sandra J. Casak, Pallavi S. Mishra-Kalyani, Pourab Roy, Julia A. Beaver, Richard Pazdur, Paul G. Kluetz, Steven J. Lemery, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (24): 5244–5248.
https://doi.org/10.1158/1078-0432.CCR-22-0617
Published: 15 December 2022
View article titled, FDA Approval Summary: Nivolumab for the Adjuvant Treatment of Adults with Completely Resected Esophageal/Gastroesophageal Junction Cancer and Residual Pathologic Disease
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Journal Articles

FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation

Sandra J. Casak, Shan Pradhan, Lola A. Fashoyin-Aje, Yi Ren, Yuan-Li Shen, Yuan Xu, Edwin Chiu Yuen Chow, Ye Xiong, Jeanne Fourie Zirklelbach, Jiang Liu, Rosane Charlab, William F. Pierce, Nataliya Fesenko, Julia A. Beaver, Richard Pazdur, Paul G. Kluetz, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (13): 2733–2737.
https://doi.org/10.1158/1078-0432.CCR-21-4462
Published: 01 July 2022
View article titled, FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation
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Journal Articles

FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma

Sandra J. Casak, Leigh Marcus, Lola Fashoyin-Aje, Sirisha L. Mushti, Joyce Cheng, Yuan-Li Shen, William F. Pierce, Leah Her, Kirsten B. Goldberg, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (17): 4680–4684.
https://doi.org/10.1158/1078-0432.CCR-21-0557
Published: 01 September 2021
View article titled, FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma
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Journal Articles

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

Sandra J. Casak, Martha Donoghue, Lola Fashoyin-Aje, Xiaoping Jiang, Lisa Rodriguez, Yuan-Li Shen, Yuan Xu, Xiling Jiang, Jiang Liu, Hong Zhao, William F. Pierce, Shubhangi Mehta, Kirsten B. Goldberg, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1836–1841.
https://doi.org/10.1158/1078-0432.CCR-20-3407
Published: 01 April 2021
View article titled, FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma
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Journal Articles

FDA's Approval of the First Biosimilar to Bevacizumab

Sandra J. Casak, Steven J. Lemery, Jee Chung, Chana Fuchs, Sarah J. Schrieber, Edwin C.Y. Chow, Weishi Yuan, Lisa Rodriguez, Thomas Gwise, Anne Rowzee, Sue Lim, Patricia Keegan, Amy E. McKee, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (18): 4365–4370.
https://doi.org/10.1158/1078-0432.CCR-18-0566
Published: 14 September 2018
View article titled, FDA's Approval of the First Biosimilar to Bevacizumab
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Journal Articles

FDA Approval Summary: Ramucirumab for Gastric Cancer

Sandra J. Casak, Ibilola Fashoyin-Aje, Steven J. Lemery, Lillian Zhang, Runyan Jin, Hongshan Li, Liang Zhao, Hong Zhao, Hui Zhang, Huanyu Chen, Kun He, Michele Dougherty, Rachel Novak, Sarah Kennett, Sachia Khasar, Whitney Helms, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (15): 3372–3376.
https://doi.org/10.1158/1078-0432.CCR-15-0600
Published: 02 August 2015
View article titled, FDA Approval Summary: Ramucirumab for Gastric Cancer
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