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FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors
Leigh Marcus, Martha Donoghue, Stephanie Aungst, Claire E. Myers, Whitney S. Helms, Guoxiang Shen, Hong Zhao, Olen Stephens, Patricia Keegan, Richard Pazdur

Clinical Cancer Research Sep 2020, DOI: 10.1158/1078-0432.CCR-20-2771
FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma
Elaine Chang, Chana Weinstock, Lijun Zhang, Rosane Charlab, Sarah E. Dorff, Yutao Gong, Vicky Hsu, Fang Li, Tiffany K. Ricks, Pengfei Song, Shenghui Tang, Peter E. Waldron, Jingyu Yu, Eias Zahalka, Kirsten B. Goldberg, Richard Pazdur, Marc R. Theoret, Amna Ibrahim, Julia A. Beaver

Clinical Cancer Research Sep 2020, DOI: 10.1158/1078-0432.CCR-20-2275
FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
Sonia Singh, Adnan A. Jaigirdar, Flora Mulkey, Joyce Cheng, Salaheldin S. Hamed, Yangbing Li, Jiang Liu, Hong Zhao, Anwar Goheer, Whitney S. Helms, Xing Wang, Rajiv Agarwal, Rajan Pragani, Kwadwo Korsah, Shenghui Tang, John Leighton, Atiqur Rahman, Julia A. Beaver, Richard Pazdur, Marc R. Theoret, Harpreet Singh

Clinical Cancer Research Dec 2020, DOI: 10.1158/1078-0432.CCR-20-3901
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

Clinical Cancer Research Nov 2020, DOI: 10.1158/1078-0432.CCR-20-3407
FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid cancers with RET Gene Mutations or Fusions
Diana Bradford, Erin Larkins, Sirisha L Mushti, Lisa Rodriguez, Amy M Skinner, Whitney S. Helms, Lauren S. L. Price, Jeanne Fourie Zirkelbach, Yangbing Li, Jiang Liu, Rosane Charlab, Francisca Reyes Turcu, Dun Liang, Soma Ghosh, Donna Roscoe, Reena Philip, Autumn Zack-Taylor, Shenghui Tang, Paul G. Kluetz, Julia A Beaver, Richard Pazdur, Marc R. Theoret, Harpreet Singh

Clinical Cancer Research Jan 2020, clincanres.3558.2020; DOI: 10.1158/1078-0432.CCR-20-3558
FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf injection for subcutaneous use in Patients with HER2-Positive Breast Cancer
Jennifer J Gao, Christy L. Osgood, Yutao Gong, Hui Zhang, Erik W Bloomquist, Xiling Jiang, Junshan Qiu, Jingyu Yu, Pengfei Song, Atiqur Rahman, Haw-Jyh Chiu, Tiffany K. Ricks, Fatima Rizvi, Sherry Hou, Willie Wilson, Abde M. Abukhdeir, Jeffrey Seidman, Soma Ghosh, Reena Philip, William F Pierce, Vishal Bhatnagar, Paul G. Kluetz, Richard Pazdur, Julia A Beaver, Laleh Amiri-Kordestani

Clinical Cancer Research Jan 2020, clincanres.3474.2020; DOI: 10.1158/1078-0432.CCR-20-3474
FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third Line Treatment of Metastatic Triple-negative Breast Cancer (mTNBC)
Sakar Wahby, Lola Fashoyin-Aje, Christy L. Osgood, Joyce Cheng, Mallorie H. Fiero, Lijun Zhang, Shenghui Tang, Salaheldin S Hamed, Pengfei Song, Rosane Charlab, Sarah E. Dorff, Tiffany K. Ricks, Kimberly Barnett-Ringgold, Jeannette Dinin, Kirsten B. Goldberg, Marc R. Theoret, Richard Pazdur, Laleh Amiri-Kordestani, Julia A Beaver

Clinical Cancer Research Jan 2020, clincanres.3119.2020; DOI: 10.1158/1078-0432.CCR-20-3119
FDA Approval Summary: Alpelisib plus fulvestrant for patients with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer
Preeti Narayan, Tatiana M. Prowell, Jennifer J Gao, Laura L. Fernandes, Emily Li, Xiling Jiang, Junshan Qiu, Jianghong Fan, Pengfei Song, Jingyu Yu, Xinyuan Zhang, Bellinda L. King-Kallimanis, Wei Chen, Tiffany K. Ricks, Yutao Gong, Xing Wang, Katherine Windsor, Steve Y Rhieu, Gerlie Gieser, Anamitro Banerjee, Xiaohong Chen, Francisca Reyes Turcu, Deb K Chatterjee, Anand Pathak, Jeffrey Seidman, Soma Ghosh, Reena Philip, Kirsten B. Goldberg, Paul G. Kluetz, Shenghui Tang, Laleh Amiri-Kordestani, Marc R. Theoret, Richard Pazdur, Julia A Beaver

Clinical Cancer Research Jan 2020, clincanres.3652.2020; DOI: 10.1158/1078-0432.CCR-20-3652
FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-Positive Breast Cancer
Mirat Shah, Suparna Wedam, Joyce Cheng, Mallorie H. Fiero, Huiming Xia, Fang Li, Jianghong Fan, Xinyuan Zhang, Jingyu Yu, Pengfei Song, Wei Chen, Tiffany K. Ricks, Xiao Hong Chen, Kirsten B. Goldberg, Yutao Gong, William F Pierce, Shenghui Tang, Marc R. Theoret, Richard Pazdur, Laleh Amiri-Kordestani, Julia A Beaver

Clinical Cancer Research Jan 2020, clincanres.2701.2020; DOI: 10.1158/1078-0432.CCR-20-2701
FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis
Shaily Arora, Sanjeeve Balasubramaniam, Wei Zhang, Lijun Zhang, Rajeshwari Sridhara, Dianne Spillman, Jaigi P. Mathai, Bradley Scott, Sarah J. Golding, Michael Coory, Richard Pazdur, Julia A. Beaver

Clinical Cancer Research Oct 2020, 26 (19) 5062-5067; DOI: 10.1158/1078-0432.CCR-19-3979

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