The Wild West of Checkpoint Inhibitor Development von Beaver, Julia A, Pazdur, Richard

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Reevaluating Eligibility Criteria — Balancing Patient Protection and Participation in Oncology Trials von Beaver, Julia A, Ison, Gwynn, Pazdur, Richard

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FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC von Nakajima, Erica C, Drezner, Nicole, Li, Xiaoxue, Mishra-Kalyani, Pallavi S, Liu, Yajun, Zhao, Hong, Bi, Youwei, Liu, Jiang, Rahman, Atiqur, Wearne, Emily, Ojofeitimi, Idara, Hotaki, Lauren Tesh, Spillman, Dianne, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet

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Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody von Maher, V Ellen, Fernandes, Laura L, Weinstock, Chana, Tang, Shenghui, Agarwal, Sundeep, Brave, Michael, Ning, Yang-Min, Singh, Harpreet, Suzman, Daniel, Xu, James, Goldberg, Kirsten B, Sridhara, Rajeshwari, Ibrahim, Amna, Theoret, Marc, Beaver, Julia A, 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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Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement von Kim, Edward S, Bruinooge, Suanna S, Roberts, Samantha, Ison, Gwynn, Lin, Nancy U, Gore, Lia, Uldrick, Thomas S, Lichtman, Stuart M, Roach, Nancy, Beaver, Julia A, Sridhara, Rajeshwari, Hesketh, Paul J, Denicoff, Andrea M, Garrett-Mayer, Elizabeth, Rubin, Eric, Multani, Pratik, Prowell, Tatiana M, Schenkel, Caroline, Kozak, Marina, Allen, Jeff, Sigal, Ellen, Schilsky, Richard L

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FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis von Arora, Shaily, Balasubramaniam, Sanjeeve, Zhang, Wei, Zhang, Lijun, Sridhara, Rajeshwari, Spillman, Dianne, Mathai, Jaigi P., Scott, Bradley, Golding, Sarah J., Coory, Michael, Pazdur, Richard, Beaver, Julia A.

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US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non-Small-Cell Lung Cancer von Akinboro, Oladimeji, Drezner, Nicole, Amatya, Anup, Runyan, Jin, Fourie-Zirkelbach, Jeanne, Zhao, Miao, Bi, Youwei, Korsah, Kwadwo, Mixter, Bronwyn, Tang, Shenghui, Larkins, Erin, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet

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FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer von Wahby, Sakar, Fashoyin-Aje, Lola, Osgood, Christy L., Cheng, Joyce, Fiero, Mallorie H., Zhang, Lijun, Tang, Shenghui, Hamed, Salaheldin S., Song, Pengfei, Charlab, Rosane, Dorff, Sarah E., Ricks, Tiffany K., Barnett-Ringgold, Kimberly, Dinin, Jeannette, Goldberg, Kirsten B., Theoret, Marc R., Pazdur, Richard, Amiri-Kordestani, Laleh, Beaver, Julia A.

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Systematic Review of PD‐1/PD‐L1 Inhibitors in Oncology: From Personalized Medicine to Public Health von Chang, Elaine, Pelosof, Lorraine, Lemery, Steven, Gong, Yutao, Goldberg, Kirsten B., Farrell, Ann T., Keegan, Patricia, Veeraraghavan, Janaki, Wei, Guo, Blumenthal, Gideon M., Amiri‐Kordestani, Laleh, Singh, Harpreet, Fashoyin‐Aje, Lola, Gormley, Nicole, Kluetz, Paul G., Pazdur, Richard, Beaver, Julia A., Theoret, Marc R.

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

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FDA Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer von Wedam, Suparna, Fashoyin-Aje, Lola, Gao, Xin, Bloomquist, Erik, Tang, Shenghui, Sridhara, Rajeshwari, Goldberg, Kirsten B., King-Kallimanis, Bellinda L., Theoret, Marc R., Ibrahim, Amna, Amiri-Kordestani, Laleh, Pazdur, Richard, Beaver, Julia A.

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In search of autophagy biomarkers in breast cancer: Receptor status and drug agnostic transcriptional changes during autophagy flux in cell lines von Mascia, Francesca, Mazo, Ilya, Alterovitz, Wei-Lun, Karagiannis, Konstantinos, Wu, Wells W, Shen, Rong-Fong, Beaver, Julia A, Rao, V Ashutosh

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“Dangling” Accelerated Approvals in Oncology von Beaver, Julia A, Pazdur, Richard

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Advancing Assessment, Analysis, and Reporting of Safety and Tolerability in Cancer Trials von Kluetz, Paul G, King-Kallimanis, Bellinda L, Suzman, Daniel, Chang, Elaine, Brave, Michael M, Weinstock, Chana, Bhatnagar, Vishal, Beaver, Julia A, Chuk, Meredith K

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PIK3CA and AKT1 Mutations Have Distinct Effects on Sensitivity to Targeted Pathway Inhibitors in an Isogenic Luminal Breast Cancer Model System von BEAVER, Julia A, GUSTIN, John P, YI, Kyung H, RAJPUROHIT, Anandita, THOMAS, Matthew, GILBERT, Samuel F, MARC ROSEN, D, PARK, Ben Ho, LAURING, Josh

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An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies von Beaver, Julia A, Tzou, Abraham, Blumenthal, Gideon M, McKee, Amy E, Kim, Geoffrey, Pazdur, Richard, Philip, Reena

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Evaluation of somatic copy number variation detection by NGS technologies and bioinformatics tools on a hyper-diploid cancer genome von Masood, Daniall, Ren, Luyao, Nguyen, Cu, Brundu, Francesco G, Zheng, Lily, Zhao, Yongmei, Jaeger, Erich, Li, Yong, Cha, Seong Won, Halpern, Aaron, Truong, Sean, Virata, Michael, Yan, Chunhua, Chen, Qingrong, Pang, Andy, Alberto, Reyes, Xiao, Chunlin, Yang, Zhaowei, Chen, Wanqiu, Wang, Charles, Cross, Jr, Frank, Catreux, Severine, Shi, Leming, Beaver, Julia A, Xiao, Wenming, Meerzaman, Daoud M

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US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments von Wedam, Suparna B, Beaver, Julia A, Amiri-Kordestani, Laleh, Bloomquist, Erik, Tang, Shenghui, Goldberg, Kirsten B, Sridhara, Rajeshwari, Ibrahim, Amna, Kim, Geoffrey, Kluetz, Paul, McKee, Amy, Pazdur, Richard

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Regulatory implications of ctDNA in immuno-oncology for solid tumors von Vellanki, Paz J, Ghosh, Soma, Pathak, Anand, Fusco, Michael J, Bloomquist, Erik W, Tang, Shenghui, Singh, Harpreet, Philip, Reena, Pazdur, Richard, Beaver, Julia A

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