Search Results - "Osgood, Christy"

FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer by 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

“…On April 22, 2020, the FDA granted accelerated approval to sacituzumab govitecan-hziy (TRODELVY; Immunomedics, Inc.) for the treatment of patients with…”
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FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer by 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

“…On July 26, 2021, the FDA granted approval to pembrolizumab in combination with chemotherapy for neoadjuvant treatment and then continued as a single agent for…”
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FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer by Narayan, Preeti, Osgood, Christy L, Singh, Harpreet, Chiu, Haw-Jyh, Ricks, Tiffany K, Chiu Yuen Chow, Edwin, Qiu, Junshan, Song, Pengfei, Yu, Jingyu, Namuswe, Frances, Guiterrez-Lugo, Maria, Hou, Sherry, Pierce, William F, Goldberg, Kirsten B, Tang, Shenghui, Amiri-Kordestani, Laleh, Theoret, Marc R, Pazdur, Richard, Beaver, Julia A

“…On December 20, 2019, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki [DS-8201a; T-DXd; tradename ENHERTU (Daiichi Sankyo)] for the…”
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FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen by Osgood, Christy L, Chuk, Meredith K, Theoret, Marc R, Huang, Lan, He, Kun, Her, Leah, Keegan, Patricia, Pazdur, Richard

“…On January 28, 2016, the FDA approved eribulin (Halaven; Eisai Inc.) for the treatment of patients with unresectable or metastatic liposarcoma who have…”
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U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review by Arora, Shaily, Narayan, Preeti, Osgood, Christy L, Wedam, Suparna, Prowell, Tatiana M, Gao, Jennifer J, Shah, Mirat, Krol, Danielle, Wahby, Sakar, Royce, Melanie, Ghosh, Soma, Philip, Reena, Ison, Gwynn, Berman, Tara, Brus, Christina, Bloomquist, Erik W, Fiero, Mallorie H, Tang, Shenghui, Pazdur, Richard, Ibrahim, Amna, Amiri-Kordestani, Laleh, Beaver, Julia A

“…Over the last decade, the treatment of patients with breast cancer has been greatly impacted by the approval of multiple drugs and indications. This summary…”
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FDA Approval Summary: Capecitabine Labeling Update under Project Renewal by Agrawal, Sundeep, Lee, Clara, Pierce, William F, Everhart, Elizabeth, King-Ducre, Adriene, Royce, Melanie, Osgood, Christy L, Amiri-Kordestani, Laleh, Chiu, Haw-Jyh, Ricks, Tiffany K, Pan, Lili, Fourie Zirkelbach, Jeanne, Charlab, Rosane, Pacanowski, Michael, Kim, Tamy, Pazdur, Richard, Kluetz, Paul G, Gao, Jennifer J

“…On December 14, 2022, the U.S. Food and Drug Administration (FDA) approved revisions to the United States Prescribing Information (USPI) for capecitabine that…”
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FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer by Royce, Melanie, Osgood, Christy L, Amatya, Anup K, Fiero, Mallorie H, Chang, C J George, Ricks, Tiffany K, Shetty, Krithika A, Kraft, Jeffrey, Qiu, Junshan, Song, Pengfei, Charlab, Rosane, Yu, Jingyu, King, Kathryn E, Rastogi, Anshu, Janelsins, Brian, Weinberg, Wendy C, Clouse, Kathleen, Borders-Hemphill, Vicky, Brown, Lindsey, Gomez-Broughton, Candace, Li, Zhong, Nguyen, Thuy Thanh, Qiu, Zhihao, Ly, Anh-Thy, Chang, Suyoung, Gao, Tingting, Tu, Chi-Ming, King-Kallimanis, Bellinda, Pierce, William F, Chiang, Kelly, Lee, Clara, Goldberg, Kirsten B, Leighton, John K, Tang, Shenghui, Pazdur, Richard, Beaver, Julia A, Amiri-Kordestani, Laleh

“…On December 16, 2020, the FDA granted regular approval to margetuximab-cmkb (MARGENZA), in combination with chemotherapy, for the treatment of adult patients…”
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FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer by Gao, Jennifer J, Osgood, Christy L, Gong, Yutao, Zhang, Hui, Bloomquist, Erik W, Jiang, Xiling, Qiu, Junshan, Yu, Jingyu, Song, Pengfei, Rahman, Nam Atiqur, Chiu, Haw-Jyh, Ricks, Tiffany K, Rizvi, Fatima, Hou, Sherry, Wilson, Willie, Abukhdeir, Abde M, Seidman, Jeffrey, Ghosh, Soma, Philip, Reena, Pierce, William F, Bhatnagar, Vishal, Kluetz, Paul G, Pazdur, Richard, Beaver, Julia A, Amiri-Kordestani, Laleh

“…On June 29, 2020, the FDA approved pertuzumab, trastuzumab, and hyaluronidase-zzxf subcutaneous injection (Phesgo) for the treatment of patients with…”
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FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer by Gao, Jennifer J, Osgood, Christy L, Feng, Zhou, Bloomquist, Erik W, Tang, Shenghui, Chang, C J George, Ricks, Tiffany K, Hou, Sherry C, Pierce, William F, Rivera, Donna R, Pazdur, Richard, Kluetz, Paul G, Amiri-Kordestani, Laleh

“…On December 10, 2021, the FDA expanded the indications for ribociclib to include male patients for the treatment of hormone receptor-positive, HER2-negative…”
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U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review by Arora, Shaily, Narayan, Preeti, Ison, Gwynn, Berman, Tara, Suzman, Daniel L, Wedam, Suparna, Prowell, Tatiana M, Ghosh, Soma, Philip, Reena, Osgood, Christy L, Gao, Jennifer J, Shah, Mirat, Krol, Danielle, Wahby, Sakar, Royce, Melanie, Brus, Christina, Bloomquist, Erik W, Fiero, Mallorie H, Tang, Shenghui, Pazdur, Richard, Ibrahim, Amna, Amiri-Kordestani, Laleh, Beaver, Julia A

“…Over the last decade, there has been tremendous progress in the treatment of patients with gynecologic cancers with a changing therapy landscape. This summary…”
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Identification of Mithramycin Analogues with Improved Targeting of the EWS-FLI1 Transcription Factor by Osgood, Christy L, Maloney, Nichole, Kidd, Christopher G, Kitchen-Goosen, Susan, Segars, Laura, Gebregiorgis, Meti, Woldemichael, Girma M, He, Min, Sankar, Savita, Lessnick, Stephen L, Kang, Min, Smith, Malcolm, Turner, Lisa, Madaj, Zachary B, Winn, Mary E, Núñez, Luz-Elena, González-Sabín, Javier, Helman, Lee J, Morís, Francisco, Grohar, Patrick J

“…The goal of this study was to identify second-generation mithramycin analogues that better target the EWS-FLI1 transcription factor for Ewing sarcoma. We…”
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Clostridium difficile infection in the pediatric transplant patient by Nicholson, Maribeth R., Osgood, Christy L., Acra, Sari A., Edwards, Kathryn M.

“…CDIs are on the rise in both hospital and community settings in adults and children. Children with cancer or a history of HSCT or SOT appear to be at higher…”
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18F-FLT Positron Emission Tomography (PET) is a Pharmacodynamic Marker for EWS-FLI1 Activity and Ewing Sarcoma by Osgood, Christy L., Tantawy, Mohammed N., Maloney, Nichole, Madaj, Zachary B., Peck, Anderson, Boguslawski, Elissa, Jess, Jennifer, Buck, Jason, Winn, Mary E., Manning, H. Charles, Grohar, Patrick J.

“…Ewing sarcoma is a bone and soft-tissue tumor that depends on the activity of the EWS-FLI1 transcription factor for cell survival. Although a number of…”
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US Food and Drug Administration Expanded Adjuvant Indication of Abemaciclib in High-Risk Early Breast Cancer by Royce, Melanie, Mulkey, Flora, Osgood, Christy, Bloomquist, Erik, Amiri-Kordestani, Laleh

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FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer by 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

“…The US Food and Drug Administration approved abemaciclib in combination with endocrine therapy (ET) for the adjuvant treatment of adult patients with hormone…”
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US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer by Narayan, Preeti, Dilawari, Asma, Osgood, Christy, Feng, Zhou, Bloomquist, Erik, Pierce, William F, Jafri, Samina, Kalavar, Shyam, Kondratovich, Marina, Jha, Prakash, Ghosh, Soma, Tang, Shenghui, Pazdur, Richard, Beaver, Julia A, Amiri-Kordestani, Laleh

“…The US Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (DS-8201a, T-DXd) for the treatment of adult patients with unresectable or…”
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Updated FDA pooled analysis of pain medication use in trial participants with HR+, HER2-negative metastatic breast cancer treated with endocrine therapy and a CDK 4/6 inhibitor by Gao, Jennifer J, Girvin, Andrew, Hodgdon, Christine, Osgood, Christy, Ison, Gwynn, Bhatnagar, Vishal, Kluetz, Paul Gustav, Pazdur, Richard, Amiri-Kordestani, Laleh, Beaver, Julia A.

“…e24101 Background: Pain medications (PMs) are commonly used to treat pain in patients with advanced or metastatic breast cancer (MBC). We previously reported…”
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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 by 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, Amiri-Kordestani, Laleh

“…Cyclin-dependent kinase 4/6 inhibitors (CDKIs) are oral targeted agents approved for use in combination with endocrine therapy as first-line or second-line…”
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Abstract P5-19-02: Methodological approaches to the use of real-world data(RWD) for medical products to treat breast cancer: An FDA oncology center of excellence evaluation of RWD submissions by Royce, Melanie E, Lee, Jennifer J., Osgood, Christy L., Amiri-Kordestani, Laleh, Beaver, Julia A., Kluetz, Paul G., Rivera, Donna R.

“…Background: Aligning with 21st Century Cures legislation, FDA is exploring various methodologies to advance appropriate uses of Real-World Data (RWD) to…”
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Abstract P2-11-05: Generating real-world external comparators for randomized clinical trials (RCTs) in metastatic breast cancer (mBC) using electronic health records (EHRs) by Amiri-Kordestani, Laleh, Gao, Xin, Baxi, Shrujal, Bloomquist, Erik, Bryan, Jonathan, Howie, Lynn, Keane, Catherine, Kluetz, Paul G., Osgood, Christy, Paliwal, Prashni, Rivera, Donna R., Roose, James, Schneider, Julie, Singh, Harpreet, Tang, Shenghui, Zhang, Lijun, Beaver, Julia A.

“…Objectives: Real-world data (RWD) from the routine care of patients with cancer captured through EHRs is a valuable resource for research. Understanding the…”
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