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519 results on '"Beaver, Julia A."'

1. Evaluation of somatic copy number variation detection by NGS technologies and bioinformatics tools on a hyper-diploid cancer genome

Author

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, and Meerzaman, Daoud M.

Published
2024
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5. Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence Public Workshop.

Author

Weinstock, Chana, Suzman, Daniel, Kluetz, Paul, Baxley, John, Viviano, Charles, Ibrahim, Amna, Jarow, Jonathan, Sridhara, Raejshwari, Liu, Ke, Carroll, Peter, Eggener, Scott, Hu, Jim C, Hussain, Maha, King, Martin, Klein, Eric, Kungel, Terry, Makarov, Danil, Pinto, Peter A, Rini, Brian, Roach, Mack, Sandler, Howard, Schlegel, Peter N, Song, Daniel, Goldberg, Kirsten, Pazdur, Richard, and Beaver, Julia A

Subjects
Humans, Prostatic Neoplasms, Diagnostic Imaging, Endpoint Determination, Population Surveillance, Genomics, Research Design, United States Food and Drug Administration, Education, United States, Male, Clinical Trials as Topic, Watchful Waiting, drug development, equipment design, prostatic neoplasms, research design, Urologic Diseases, Cancer, Prostate Cancer, Aging, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, United States Food and Drug, Administration, Clinical Sciences, Urology & Nephrology
Abstract

PurposeThe following is a summary of discussion at a United States FDA (Food and Drug Administration) public workshop reviewing potential trial designs and end points to develop therapies to treat localized prostate cancer.Materials and methodsThe workshop focused on the challenge that drug and device development to treat localized prostate cancer has been limited by the large trial sizes and lengthy timelines required to demonstrate an improvement in overall or metastasis-free survival and by the lack of agreed on alternative end points. Additionally, evolving treatment paradigms in the management of localized prostate cancer include the widespread use of active surveillance of patients with low and some intermediate risk prostate cancer, and the availability of advances in imaging and genomics.ResultsThe workshop addressed issues related to trial design in this setting. Attendees discussed several potential novel end points such as a delay of morbidity due to radiation or prostatectomy and pathological end points such as Gleason Grade Group upgrade.ConclusionsThe workshop provided an open forum for multiple stakeholder engagement to advance the development of effective treatment options for men with localized prostate cancer.

Published
2020

6. Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop

Author

Chang, Elaine, Apolo, Andrea B., Bangs, Rick, Chisolm, Stephanie, Duddalwar, Vinay, Efstathiou, Jason A., Goldberg, Kirsten B., Hansel, Donna E., Kamat, Ashish M., Kluetz, Paul G., Lerner, Seth P., Plimack, Elizabeth, Prowell, Tatiana, Singh, Harpreet, Suzman, Daniel, Yu, Evan Y., Zhang, Hui, Beaver, Julia A., Pazdur, Richard, Weinstock, Chana, and Galsky, Matthew D.

Published
2022
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7. FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations.

Author

Mehta, Gautam U, Vellanki, Paz J, Ren, Yi, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Pan, Lili, Zirkelbach, Jeanne F, Pan, Yuzhuo, Liu, Jiang, Aungst, Stephanie L, Miller, Claudia P, Shah, Mirat, Rahman, Nam Atiqur, Theoret, Marc, Kluetz, Paul, Pazdur, Richard, Beaver, Julia A, and Singh, Harpreet

Subjects
TRASTUZUMAB, PATIENT safety, FATIGUE (Physiology), BALDNESS, APPETITE, INTERSTITIAL lung diseases, DRUG approval, METASTASIS, ONCOGENES, LUNG cancer, GENETIC mutation, VOMITING, NAUSEA, CONSTIPATION
Abstract

On August 11, 2022, FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (DS-8201a, T-DXd, ENHERTU, Daiichi Sankyo) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. The approval was based on a prespecified interim analysis of DESTINY-Lung02 (Study U206), a multi-center, randomized, dose-optimization trial in patients with NSCLC harboring activating HER2 -mutations. At the approved dose of 5.4 mg/kg given intravenously every 3 weeks, the overall response rate (ORR) was 58% (95% confidence interval [CI]: 43, 71). The median duration of response was 8.7 months (95% CI: 7.1, not estimable). These results were consistent with response rates observed at the 6.4 mg/kg dose level. The most common (≥ 20%) adverse reactions were nausea, constipation, decreased appetite, vomiting, fatigue, and alopecia. The rate of interstitial lung disease (ILD) or pneumonitis was 6% at the 5.4 mg/kg dose level and 14% at the 6.4 mg/kg dose level. In the setting of similar efficacy and reduced toxicity, approval was granted for the 5.4 mg/kg dose level. The applicant conducted a randomized, dose-optimization study with guidance from the FDA Oncology Center of Excellence's Project Optimus. This is the first approval of a targeted therapy for HER2 -mutated NSCLC. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis

Author

Gao, Jennifer J, Cheng, Joyce, Prowell, Tatiana M, Bloomquist, Erik, Tang, Shenghui, Wedam, Suparna B, Royce, Melanie, Krol, Danielle, Osgood, Christy, Ison, Gwynn, Sridhara, Rajeshwari, Pazdur, Richard, Beaver, Julia A, and Amiri-Kordestani, Laleh

Published
2021
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10. Supplementary Table S1 from FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum

Author

Singh, Sonia, primary, Bradford, Diana, primary, Li, Xiaoxue, primary, Mishra-Kalyani, Pallavi S., primary, Shen, Yuan-Li, primary, Wang, Lingshan, primary, Zhao, Hong, primary, Xiong, Ye, primary, Liu, Jiang, primary, Charlab, Rosane, primary, Kraft, Jeffrey, primary, Khasar, Sachia, primary, Miller, Claudia P., primary, Rivera, Donna R., primary, Kluetz, Paul G., primary, Pazdur, Richard, primary, Beaver, Julia A., primary, Singh, Harpreet, primary, and Donoghue, Martha, primary

Published
2024
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11. Data from FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum

Author

Singh, Sonia, primary, Bradford, Diana, primary, Li, Xiaoxue, primary, Mishra-Kalyani, Pallavi S., primary, Shen, Yuan-Li, primary, Wang, Lingshan, primary, Zhao, Hong, primary, Xiong, Ye, primary, Liu, Jiang, primary, Charlab, Rosane, primary, Kraft, Jeffrey, primary, Khasar, Sachia, primary, Miller, Claudia P., primary, Rivera, Donna R., primary, Kluetz, Paul G., primary, Pazdur, Richard, primary, Beaver, Julia A., primary, Singh, Harpreet, primary, and Donoghue, Martha, primary

Published
2024
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12. Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials

Author

Fallah, Jaleh, Zhang, Lijun, Amatya, Anup, Gong, Yutao, King-Kallimanis, Bellinda, Bhatnagar, Vishal, Weinstock, Chana, Suzman, Daniel L, Agrawal, Sundeep, Chang, Elaine, Anscher, Mitchell S, Chi, Dow-Chung, Xu, James X, Brewer, Jamie R, Brave, Michael H, Hadadi, Mehrnoosh, Theoret, Marc R, Kluetz, Paul G, Goldberg, Kirsten B, Ibrahim, Amna, Tang, Shenghui, Pazdur, Richard, Beaver, Julia A, Amiri-Kordestani, Laleh, and Singh, Harpreet

Published
2021
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14. Changes in Circulating Tumor DNA Reflect Clinical Benefit Across Multiple Studies of Patients With Non–Small-Cell Lung Cancer Treated With Immune Checkpoint Inhibitors

Author

Vega, Diana Merino, Nishimura, Katherine K., Zariffa, Névine, Thompson, Jeffrey C., Hoering, Antje, Cilento, Vanessa, Rosenthal, Adam, Anagnostou, Valsamo, Baden, Jonathan, Beaver, Julia A., Chaudhuri, Aadel A., Chudova, Darya, Fine, Alexander D., Fiore, Joseph, Hodge, Rachel, Hodgson, Darren, Hunkapiller, Nathan, Klass, Daniel M., Kobie, Julie, Peña, Carol, Pennello, Gene, Peterman, Neil, Philip, Reena, Quinn, Katie J., Raben, David, Rosner, Gary L., Sausen, Mark, Tezcan, Ayse, Xia, Qi, Yi, Jing, Young, Amanda G., Stewart, Mark D., Carpenter, Erica L., Aggarwal, Charu, and Allen, Jeff

Published
2022
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16. CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis

Author

Gao, Jennifer J, Cheng, Joyce, Bloomquist, Erik, Sanchez, Jacquelyn, Wedam, Suparna B, Singh, Harpreet, Amiri-Kordestani, Laleh, Ibrahim, Amna, Sridhara, Rajeshwari, Goldberg, Kirsten B, Theoret, Marc R, Kluetz, Paul G, Blumenthal, Gideon M, Pazdur, Richard, Beaver, Julia A, and Prowell, Tatiana M

Published
2020
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17. FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum

Author

Singh, Sonia, primary, Bradford, Diana, additional, Li, Xiaoxue, additional, Mishra-Kalyani, Pallavi S., additional, Shen, Yuan-Li, additional, Wang, Lingshan, additional, Zhao, Hong, additional, Xiong, Ye, additional, Liu, Jiang, additional, Charlab, Rosane, additional, Kraft, Jeffrey, additional, Khasar, Sachia, additional, Miller, Claudia P., additional, Rivera, Donna R., additional, Kluetz, Paul G., additional, Pazdur, Richard, additional, Beaver, Julia A., additional, Singh, Harpreet, additional, and Donoghue, Martha, additional

Published
2023
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20. 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

Author

Akinboro, Oladimeji, primary, Drezner, Nicole, additional, Amatya, Anup, additional, Runyan, Jin, additional, Fourie-Zirkelbach, Jeanne, additional, Zhao, Miao, additional, Bi, Youwei, additional, Korsah, Kwadwo, additional, Mixter, Bronwyn, additional, Tang, Shenghui, additional, Larkins, Erin, additional, Pazdur, Richard, additional, Beaver, Julia A., additional, and Singh, Harpreet, additional

Published
2023
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21. FDA Approval Summary: Amivantamab for the Treatment of Patients with Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Author

Chon, Katie, primary, Larkins, Erin, additional, Chatterjee, Somak, additional, Mishra-Kalyani, Pallavi S., additional, Aungst, Stephanie, additional, Wearne, Emily, additional, Subramaniam, Sriram, additional, Li, Yangbing, additional, Liu, Jiang, additional, Sun, Jielin, additional, Charlab, Rosane, additional, Zhao, Hong, additional, Saritas-Yildirim, Banu, additional, Bikkavilli, Rama Kamesh, additional, Ghosh, Soma, additional, Philip, Reena, additional, Beaver, Julia A., additional, and Singh, Harpreet, additional

Published
2023
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26. Data from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

Author

Singh, Sonia, primary, Jaigirdar, Adnan A., primary, Mulkey, Flora, primary, Cheng, Joyce, primary, Hamed, Salaheldin S., primary, Li, Yangbing, primary, Liu, Jiang, primary, Zhao, Hong, primary, Goheer, Anwar, primary, Helms, Whitney S., primary, Wang, Xing, primary, Agarwal, Rajiv, primary, Pragani, Rajan, primary, Korsah, Kwadwo, primary, Tang, Shenghui, primary, Leighton, John, primary, Rahman, Atiqur, primary, Beaver, Julia A., primary, Pazdur, Richard, primary, Theoret, Marc R., primary, and Singh, Harpreet, primary

Published
2023
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27. Supplementary Tables S1-S3 from The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology

Author

Schneider, Julie A., primary, Gong, Yutao, primary, Goldberg, Kirsten B., primary, Kluetz, Paul G., primary, Theoret, Marc R., primary, Amiri-Kordestani, Laleh, primary, Beaver, Julia A., primary, Fashoyin-Aje, Lola, primary, Gormley, Nicole J., primary, Jaigirdar, Adnan A., primary, Lemery, Steven J., primary, Mishra-Kalyani, Pallavi S., primary, Reaman, Gregory H., primary, Rivera, Donna R., primary, Rubinstein, Wendy S., primary, Singh, Harpreet, primary, Sridhara, Rajeshwari, primary, and Pazdur, Richard, primary

Published
2023
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28. Supplementary Tables S1 and S2 from FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

Author

Singh, Sonia, primary, Jaigirdar, Adnan A., primary, Mulkey, Flora, primary, Cheng, Joyce, primary, Hamed, Salaheldin S., primary, Li, Yangbing, primary, Liu, Jiang, primary, Zhao, Hong, primary, Goheer, Anwar, primary, Helms, Whitney S., primary, Wang, Xing, primary, Agarwal, Rajiv, primary, Pragani, Rajan, primary, Korsah, Kwadwo, primary, Tang, Shenghui, primary, Leighton, John, primary, Rahman, Atiqur, primary, Beaver, Julia A., primary, Pazdur, Richard, primary, Theoret, Marc R., primary, and Singh, Harpreet, primary

Published
2023
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29. Supplementary Tables S1-S3 from FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions

Author

Kim, Janice, primary, Bradford, Diana, primary, Larkins, Erin, primary, Pai-Scherf, Lee H., primary, Chatterjee, Somak, primary, Mishra-Kalyani, Pallavi S., primary, Wearne, Emily, primary, Helms, Whitney S., primary, Ayyoub, Amal, primary, Bi, Youwei, primary, Sun, Jielin, primary, Charlab, Rosane, primary, Liu, Jiang, primary, Zhao, Hong, primary, Liang, Dun, primary, Ghosh, Soma, primary, Philip, Reena, primary, Pazdur, Richard, primary, Theoret, Marc R., primary, Beaver, Julia A., primary, and Singh, Harpreet, primary

Published
2023
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30. Supplementary Figure 1 from Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Author

Norsworthy, Kelly J., primary, Mulkey, Flora, primary, Scott, Emma C., primary, Ward, Ashley F., primary, Przepiorka, Donna, primary, Charlab, Rosane, primary, Dorff, Sarah E., primary, Deisseroth, Albert, primary, Kazandjian, Dickran, primary, Sridhara, Rajeshwari, primary, Beaver, Julia A., primary, Farrell, Ann T., primary, de Claro, R. Angelo, primary, and Pazdur, Richard, primary

Published
2023
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32. Supplementary Table S1 from FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review

Author

Koch, Abigail L., primary, Vellanki, Paz J., primary, Drezner, Nicole, primary, Li, Xiaoxue, primary, Mishra-Kalyani, Pallavi S., primary, Shen, Yuan Li, primary, Xia, Huiming, primary, Li, Yangbing, primary, Liu, Jiang, primary, Zirkelbach, Jeanne Fourie, primary, Palazov, Elitza, primary, Gamarian, Aleksandr, primary, Choo, Qiuyi, primary, Girčys, Arūnas, primary, Rohr, Ulrich-Peter, primary, Fesenko, Nataliya, primary, Spillman, Dianne, primary, Pazdur, Richard, primary, Beaver, Julia A., primary, and Singh, Harpreet, primary

Published
2023
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34. Supplemental Data from Individualized Molecular Analyses Guide Efforts (IMAGE): A Prospective Study of Molecular Profiling of Tissue and Blood in Metastatic Triple-Negative Breast Cancer

Author

Parsons, Heather A., primary, Beaver, Julia A., primary, Cimino-Mathews, Ashley, primary, Ali, Siraj M., primary, Axilbund, Jennifer, primary, Chu, David, primary, Connolly, Roisin M., primary, Cochran, Rory L., primary, Croessmann, Sarah, primary, Clark, Travis A., primary, Gocke, Christopher D., primary, Jeter, Stacie C., primary, Kennedy, Mark R., primary, Lauring, Josh, primary, Lee, Justin, primary, Lipson, Doron, primary, Miller, Vincent A., primary, Otto, Geoff A., primary, Rosner, Gary L., primary, Ross, Jeffrey S., primary, Slater, Shannon, primary, Stephens, Philip J., primary, VanDenBerg, Dustin A., primary, Wolff, Antonio C., primary, Young, Lauren E., primary, Zabransky, Daniel J., primary, Zhang, Zhe, primary, Zorzi, Jane, primary, Stearns, Vered, primary, and Park, Ben H., primary

Published
2023
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35. Supplementary Data from FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions

Author

Bradford, Diana, primary, Larkins, Erin, primary, Mushti, Sirisha L., primary, Rodriguez, Lisa, primary, Skinner, Amy M., primary, Helms, Whitney S., primary, Price, Lauren S.L., primary, Zirkelbach, Jeanne Fourie, primary, Li, Yangbing, primary, Liu, Jiang, primary, Charlab, Rosane, primary, Turcu, Francisca Reyes, primary, Liang, Dun, primary, Ghosh, Soma, primary, Roscoe, Donna, primary, Philip, Reena, primary, Zack-Taylor, Autumn, primary, Tang, Shenghui, primary, Kluetz, Paul G., primary, Beaver, Julia A., primary, Pazdur, Richard, primary, Theoret, Marc R., primary, and Singh, Harpreet, primary

Published
2023
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36. Supplementary Tables from Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Author

Norsworthy, Kelly J., primary, Mulkey, Flora, primary, Scott, Emma C., primary, Ward, Ashley F., primary, Przepiorka, Donna, primary, Charlab, Rosane, primary, Dorff, Sarah E., primary, Deisseroth, Albert, primary, Kazandjian, Dickran, primary, Sridhara, Rajeshwari, primary, Beaver, Julia A., primary, Farrell, Ann T., primary, de Claro, R. Angelo, primary, and Pazdur, Richard, primary

Published
2023
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39. Supplementary Figure 2 from Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Author

Norsworthy, Kelly J., primary, Mulkey, Flora, primary, Scott, Emma C., primary, Ward, Ashley F., primary, Przepiorka, Donna, primary, Charlab, Rosane, primary, Dorff, Sarah E., primary, Deisseroth, Albert, primary, Kazandjian, Dickran, primary, Sridhara, Rajeshwari, primary, Beaver, Julia A., primary, Farrell, Ann T., primary, de Claro, R. Angelo, primary, and Pazdur, Richard, primary

Published
2023
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40. Supplementary Figure 3 from Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Author

Norsworthy, Kelly J., primary, Mulkey, Flora, primary, Scott, Emma C., primary, Ward, Ashley F., primary, Przepiorka, Donna, primary, Charlab, Rosane, primary, Dorff, Sarah E., primary, Deisseroth, Albert, primary, Kazandjian, Dickran, primary, Sridhara, Rajeshwari, primary, Beaver, Julia A., primary, Farrell, Ann T., primary, de Claro, R. Angelo, primary, and Pazdur, Richard, primary

Published
2023
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41. Supplementary Methods, Figures 1 - 3, Tables 1 - 4 from Detection of Cancer DNA in Plasma of Patients with Early-Stage Breast Cancer

Author

Beaver, Julia A., primary, Jelovac, Danijela, primary, Balukrishna, Sasidharan, primary, Cochran, Rory L., primary, Croessmann, Sarah, primary, Zabransky, Daniel J., primary, Wong, Hong Yuen, primary, Valda Toro, Patricia, primary, Cidado, Justin, primary, Blair, Brian G., primary, Chu, David, primary, Burns, Timothy, primary, Higgins, Michaela J., primary, Stearns, Vered, primary, Jacobs, Lisa, primary, Habibi, Mehran, primary, Lange, Julie, primary, Hurley, Paula J., primary, Lauring, Josh, primary, VanDenBerg, Dustin A., primary, Kessler, Jill, primary, Jeter, Stacie, primary, Samuels, Michael L., primary, Maar, Dianna, primary, Cope, Leslie, primary, Cimino-Mathews, Ashley, primary, Argani, Pedram, primary, Wolff, Antonio C., primary, and Park, Ben Ho, primary

Published
2023
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42. FDA Approval Summary: Atezolizumab as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Stage II to IIIA NSCLC

Author

Mathieu, Luckson N., primary, Larkins, Erin, additional, Sinha, Arup K., additional, Mishra-Kalyani, Pallavi S., additional, Jafri, Samina, additional, Kalavar, Shyam, additional, Ghosh, Soma, additional, Goldberg, Kirsten B., additional, Pazdur, Richard, additional, Beaver, Julia A., additional, and Singh, Harpreet, additional

Published
2023
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44. Abstract P2-13-03: Feasibility of generating an external control comparator using RWD by matching with previously conducted RCTs: CDK4/6 Inhibitors for the treatment of Metastatic Breast Cancer

Author

Osgood, Christy, primary, Fan, Jiaxin, additional, Gao, Xin, additional, Keane, Catherine, additional, Bryan, Jonathan, additional, Roose, James P., additional, Bloomquist, Erik, additional, Torres, Aracelis, additional, Baxi, Shrujal, additional, Nussbaum, Nathan, additional, Rizvi, Fatima, additional, Tang, Shenghui, additional, Nunes, Irene, additional, Beaver, Julia, additional, Rivera, Donna R., additional, Howie, Lynn, additional, Paliwal, Prashni, additional, and Amiri-Kordestani, Laleh, additional

Published
2023
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45. US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer

Author

Narayan, Preeti, primary, Dilawari, Asma, additional, Osgood, Christy, additional, Feng, Zhou, additional, Bloomquist, Erik, additional, Pierce, William F., additional, Jafri, Samina, additional, Kalavar, Shyam, additional, Kondratovich, Marina, additional, Jha, Prakash, additional, Ghosh, Soma, additional, Tang, Shenghui, additional, Pazdur, Richard, additional, Beaver, Julia A., additional, and Amiri-Kordestani, Laleh, additional

Published
2023
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