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Journal Articles

FDA Approval Summary: Oral Azacitidine for Continued Treatment of Adults with Acute Myeloid Leukemia Unable to Complete Intensive Curative Therapy

Emily Y. Jen, Xin Wang, Meng Li, Hongshan Li, Shwu-Luan Lee, Nina Ni, Donna Przepiorka, Jonathon Vallejo, Ruby Leong, Lian Ma, Brenda J. Gehrke, Sherita McLamore, Marc R. Theoret, R. Angelo de Claro
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (14): 2989–2993.
https://doi.org/10.1158/1078-0432.CCR-21-4525
Published: 15 July 2022
View article titled, FDA Approval Summary: Oral Azacitidine for Continued Treatment of Adults with Acute Myeloid Leukemia Unable to Complete Intensive Curative Therapy
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Journal Articles

FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1–High NSCLC

Oladimeji Akinboro, Erin Larkins, Lee H. Pai-Scherf, Luckson N. Mathieu, Yi Ren, Joyce Cheng, Mallorie H. Fiero, Wentao Fu, Youwei Bi, Shyam Kalavar, Samina Jafri, Pallavi S. Mishra-Kalyani, Jeanne Fourie Zirkelbach, Hongshan Li, Hong Zhao, Kun He, Whitney S. Helms, Meredith K. Chuk, Min Wang, Ilynn Bulatao, Jonathan Herz, Blaire L. Osborn, Yuan Xu, Jiang Liu, Yutao Gong, Sharon Sickafuse, Rebecca Cohen, Martha Donoghue, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (11): 2221–2228.
https://doi.org/10.1158/1078-0432.CCR-21-3844
Published: 01 June 2022
View article titled, FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1–High NSCLC
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Journal Articles

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma

Amy Barone, Maitreyee Hazarika, Marc R. Theoret, Pallavi Mishra-Kalyani, Huanyu Chen, Kun He, Rajeshwari Sridhara, Sriram Subramaniam, Elimika Pfuma, Yaning Wang, Hongshan Li, Hong Zhao, Jeanne Fourie Zirkelbach, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (19): 5661–5665.
https://doi.org/10.1158/1078-0432.CCR-16-0664
Published: 01 October 2017
View article titled, FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma
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Journal Articles

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma

Meredith K. Chuk, Jennie T. Chang, Marc R. Theoret, Emmanuel Sampene, Kun He, Shawna L. Weis, Whitney S. Helms, Runyan Jin, Hongshan Li, Jingyu Yu, Hong Zhao, Liang Zhao, Mark Paciga, Deborah Schmiel, Rashmi Rawat, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (19): 5666–5670.
https://doi.org/10.1158/1078-0432.CCR-16-0663
Published: 01 October 2017
View article titled, FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma
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Journal Articles

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab

Maitreyee Hazarika, Meredith K. Chuk, Marc R. Theoret, Sirisha Mushti, Kun He, Shawna L. Weis, Alexander H. Putman, Whitney S. Helms, Xianhua Cao, Hongshan Li, Hong Zhao, Liang Zhao, Joel Welch, Laurie Graham, Meredith Libeg, Rajeshwari Sridhara, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (14): 3484–3488.
https://doi.org/10.1158/1078-0432.CCR-16-0712
Published: 13 July 2017
View article titled, U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab
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Journal Articles

FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy

Geoffrey Kim, Gwynn Ison, Amy E. McKee, Hui Zhang, Shenghui Tang, Thomas Gwise, Rajeshwari Sridhara, Eunice Lee, Abraham Tzou, Reena Philip, Haw-Jyh Chiu, Tiffany K. Ricks, Todd Palmby, Anne Marie Russell, Gaetan Ladouceur, Elimika Pfuma, Hongshan Li, Liang Zhao, Qi Liu, Rajesh Venugopal, Amna Ibrahim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (19): 4257–4261.
https://doi.org/10.1158/1078-0432.CCR-15-0887
Published: 30 September 2015
View article titled, FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline <em>BRCA</em>-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy
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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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