Luminal A Breast Cancer and Molecular Assays: A Review von Gao, Jennifer J., Swain, Sandra M.

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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 von 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, Prowell, Tatiana M

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FDA Approval Summary: Olaparib Monotherapy or in Combination with Bevacizumab for the Maintenance Treatment of Patients with Advanced Ovarian Cancer von Arora, Shaily, Balasubramaniam, Sanjeeve, Zhang, Hui, Berman, Tara, Narayan, Preeti, Suzman, Daniel, Bloomquist, Erik, Tang, Shenghui, Gong, Yutao, Sridhara, Rajeshwari, Turcu, Francisca Reyes, Chatterjee, Deb, Saritas‐Yildirim, Banu, Ghosh, Soma, Philip, Reena, Pathak, Anand, Gao, Jennifer J., Amiri‐Kordestani, Laleh, Pazdur, Richard, Beaver, Julia A.

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FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1 von Narayan, Preeti, Wahby, Sakar, Gao, Jennifer J., Amiri-Kordestani, Laleh, Ibrahim, Amna, Bloomquist, Erik, Tang, Shenghui, Xu, Yuan, Liu, Jiang, Fu, Wentao, Song, Pengfei, King-Kallimanis, Bellinda L., Hou, Sherry, Gong, Yutao, Kalavar, Shyam, Ghosh, Soma, Philip, Reena, Goldberg, Kirsten B., Theoret, Marc R., Blumenthal, Gideon M., Kluetz, Paul Gustav, Sridhara, Rajeshwari, Pazdur, Richard, Beaver, Julia A.

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FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer von Narayan, Preeti, Prowell, Tatiana M., Gao, Jennifer J., Fernandes, Laura L., Li, Emily, Jiang, Xiling, Qiu, Junshan, Fan, Jianghong, Song, Pengfei, Yu, Jingyu, Zhang, Xinyuan, King-Kallimanis, Bellinda L., Chen, Wei, Ricks, Tiffany K., Gong, Yutao, Wang, Xing, Windsor, Katherine, Rhieu, Steve Y., Geiser, Gerlie, Banerjee, Anamitro, Chen, Xiaohong, Turcu, Francisca Reyes, Chatterjee, Deb K., Pathak, Anand, Seidman, Jeffrey, Ghosh, Soma, Philip, Reena, Goldberg, Kirsten B., Kluetz, Paul G., Tang, Shenghui, Amiri-Kordestani, Laleh, Theoret, Marc R., Pazdur, Richard, Beaver, Julia A.

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Outcomes of Older Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase In... von Howie, Lynn J, Singh, Harpreet, Bloomquist, Erik, Wedam, Suparna, Amiri-Kordestani, Laleh, Tang, Shenghui, Sridhara, Rajeshwari, Sanchez, Jacqueline, Prowell, Tatiana M, Kluetz, Paul G, King-Kallimanis, Belinda L, Gao, Jennifer J, Ibrahim, Amna, Goldberg, Kirsten B, Theoret, Marc, Pazdur, Richard, Beaver, Julia A

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FDA Oncology Center of Excellence Review Processes and Tools von Gao, Jennifer J., Kluetz, Paul G., Pazdur, Richard

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U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review von 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

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Advancing Therapies for Asian Americans, Native Hawaiians, and Other Pacific Islanders With Cancer: OCE's Project ASIATICA von Gao, Jennifer J, Pazdur, Richard, Kim, Tamy

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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 fulvestra... von 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

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US Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program von de Claro, R. Angelo, Gao, Jennifer J., Kim, Tamy, Kluetz, Paul G., Theoret, Marc R., Beaver, Julia A., Pazdur, Richard

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Ethnicity-based differences in breast cancer features and responsiveness to CDK4/6 inhibitors combined with endocrine therapy – Authors' reply von Gao, Jennifer J, Cheng, Joyce, Beaver, Julia A, Prowell, Tatiana M

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FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer von 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

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U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review von 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

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FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs von Kluetz, Paul G., Keegan, Patricia, Demetri, George D., Thornton, Katherine, Sul, Joohee, Kim, Janice, Katzen, Harvey, Burke, Laurie Beth, Harvey, R. Donald, Alebachew, Elleni, Agrawal, Sundeep, Nair, Abhilasha, Donoghue, Martha, Pierce, William F., Shord, Stacy S., Gao, Jennifer J., Pazdur, Richard

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HALT-D: A Phase II Evaluation of Crofelemer for the Prevention and Prophylaxis of Diarrhea in Patients With Breast Cancer on Pertuzumab-Based Regimens von Gao, Jennifer J., Tan, Ming, Pohlmann, Paula R., Swain, Sandra M.

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US Food and Drug Administration Analysis of Patient-Reported Diarrhea and Its Impact on Function and Quality of Life in Patients Receiving Treatment for Breast Cancer von Chen, Ting-Yu, King-Kallimanis, Bellinda L., Merzoug, Lyna, Horodniceanu, Erica G., Fiero, Mallorie H., Gao, Jennifer J., Beaver, Julia A., Bhatnagar, Vishal, Kluetz, Paul

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FDAApproval Summary: Olaparib Monotherapy or in Combination with Bevacizumab for the Maintenance Treatment of Patients with Advanced Ovarian Cancer von Arora, Shaily, Balasubramaniam, Sanjeeve, Zhang, Hui, Berman, Tara, Narayan, Preeti, Suzman, Daniel, Bloomquist, Erik, Tang, Shenghui, Gong, Yutao, Sridhara, Rajeshwari, Turcu, Francisca Reyes, Chatterjee, Deb, Saritas-Yildirim, Banu, Ghosh, Soma, Philip, Reena, Pathak, Anand, Gao, Jennifer J., Amiri-Kordestani, Laleh, Pazdur, Richard, Beaver, Julia A.

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Ethnicity-based differences in breast cancer features and responsiveness to CDK4/6 inhibitors combined with endocrine therapy von Gao, Jennifer J., Cheng, Joyce, Beaver, Julia A., Prowell, Tatiana M.

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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 von Gao, Jennifer J, Girvin, Andrew, Hodgdon, Christine, Osgood, Christy, Ison, Gwynn, Bhatnagar, Vishal, Kluetz, Paul Gustav, Pazdur, Richard, Amiri-Kordestani, Laleh, Beaver, Julia A.

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