FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer
Royce, Melanie, Osgood, Christy, Mulkey, Flora, Bloomquist, Erik, Pierce, William F, Roy, Arpita, Kalavar, Shyam, Ghosh, Soma, Philip, Reena, Rizvi, Fatima, Mixter, Bronwyn D, Tang, Shenghui, Pazdur, Richard, Beaver, Julia A, Amiri-Kordestani, Laleh
Published in Journal of clinical oncology (10.04.2022)
Published in Journal of clinical oncology (10.04.2022)
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FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer
Shah, Mirat, Osgood, Christy L, Amatya, Anup K, Fiero, Mallorie H, Pierce, William F, Nair, Abhilasha, Herz, Jonathan, Robertson, Kim J, Mixter, Bronwyn D, Tang, Shenghui, Pazdur, Richard, Beaver, Julia A, Amiri-Kordestani, Laleh
Published in Clinical cancer research (15.12.2022)
Published in Clinical cancer research (15.12.2022)
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FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease-Associated Tumors
Fallah, Jaleh, Brave, Michael H, Weinstock, Chana, Mehta, Gautam U, Bradford, Diana, Gittleman, Haley, Bloomquist, Erik W, Charlab, Rosane, Hamed, Salaheldin S, Miller, Claudia P, Dorff, Sarah E, Chambers, Wiley A, Mixter, Bronwyn D, Dinin, Jeannette, Pierce, William F, Ricks, Tiffany K, Tang, Shenghui, Donoghue, Martha, Pazdur, Richard, Amiri-Kordestani, Laleh, Ibrahim, Amna, Beaver, Julia A
Published in Clinical cancer research (14.11.2022)
Published in Clinical cancer research (14.11.2022)
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FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer
Dilawari, Asma, Shah, Mirat, Ison, Gwynn, Gittleman, Haley, Fiero, Mallorie H, Shah, Ankit, Hamed, Salaheldin S, Qiu, Junshan, Yu, Jingyu, Manheng, Wimolnut, Ricks, Tiffany K, Pragani, Rajan, Arudchandran, Arulvathani, Patel, Paresma, Zaman, Shadia, Roy, Arpita, Kalavar, Shyam, Ghosh, Soma, Pierce, William F, Rahman, Nam Atiqur, Tang, Shenghui, Mixter, Bronwyn D, Kluetz, Paul G, Pazdur, Richard, Amiri-Kordestani, Laleh
Published in Clinical cancer research (02.10.2023)
Published in Clinical cancer research (02.10.2023)
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US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1 -Mutated Advanced or Metastatic Breast Cancer
Shah, Mirat, Lingam, Hima, Gao, Xin, Gittleman, Haley, Fiero, Mallorie H, Krol, Danielle, Biel, Nikolett, Ricks, Tiffany K, Fu, Wentao, Hamed, Salaheldin, Li, Fang, Sun, Jillian Jielin, Fan, Jianghong, Schuck, Robert, Grimstein, Manuela, Tang, Liuya, Kalavar, Shyam, Abukhdeir, Abdelrahmman, Pathak, Anand, Ghosh, Soma, Bulatao, Ilynn, Tilley, Amy, Pierce, William F, Mixter, Bronwyn D, Tang, Shenghui, Pazdur, Richard, Kluetz, Paul, Amiri-Kordestani, Laleh
Published in Journal of clinical oncology (01.04.2024)
Published in Journal of clinical oncology (01.04.2024)
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Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development
Donaldson, Joshua M, Seddiq, Marjilla, Fusco, Michael J, Singla, Shyamli, Pamuk, Gulsum E, Lee-Alonso, Rosa J, Mixter, Bronwyn D, Goldberg, Kirsten B, Amiri-Kordestani, Laleh, de Claro, R Angelo, Drezner, Nicole, Gormley, Nicole J, Kanapuru, Bindu, Lemery, Steven J, Fashoyin-Aje, Lola A, Richardson, Nicholas C, Singh, Harpreet, Suzman, Daniel L, Theoret, Marc R, Kluetz, Paul G, Pazdur, Richard
Published in Cancer discovery (12.12.2023)
Published in Cancer discovery (12.12.2023)
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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
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
Published in Journal of clinical oncology (10.06.2023)
Published in Journal of clinical oncology (10.06.2023)
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Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development
Duke, Elizabeth S, J Fusco, Michael, DeMoss, Patrick, Dilawari, Asma, Pamuk, Gulsum E, Boehmer, Jessica, Mixter, Bronwyn, Goldberg, Kirsten B, Kluetz, Paul, Pazdur, Richard
Published in Cancer discovery (02.12.2022)
Published in Cancer discovery (02.12.2022)
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US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer With PIK3CA / AKT1 / PTEN Alterations
Dilawari, Asma, Buturla, James, Osgood, Christy, Gao, Xin, Chen, Wei, Ricks, Tiffany K, Schaefer, Timothy, Avasarala, Sreedevi, Reyes Turcu, Francisca, Pathak, Anand, Kalavar, Shyam, Bhatnagar, Vishal, Collazo, Justin, Rahman, Nam Atiqur, Mixter, Bronwyn, Tang, Shenghui, Pazdur, Richard, Kluetz, Paul, Amiri-Kordestani, Laleh
Published in Journal of clinical oncology (19.08.2024)
Published in Journal of clinical oncology (19.08.2024)
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