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ArticlesPeer ReviewedFull Text
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 / Creator:Gao, Jennifer J, MD ; Cheng, Joyce, PhD ; Bloomquist, Erik, PhD ; Sanchez, Jacquelyn, MA ; Wedam, Suparna B, MD ; Singh, Harpreet, MD ; Amiri-Kordestani, Laleh, MD ; Ibrahim, Amna, MD ; Sridhara, Rajeshwari, PhD ; Goldberg, Kirsten B, MA ; Theoret, Marc R, MD ; Kluetz, Paul G, MD ; Blumenthal, Gideon M, MD ; Pazdur, Richard, MD ; Beaver, Julia A, MD ; Prowell, Tatiana M, MD
Publisher:England: Elsevier Ltd
Journal title:The lancet oncology, 2020-02, Vol.21 (2), p.250-260
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Systematic Review of PD‐1/PD‐L1 Inhibitors in Oncology: From Personalized Medicine to Public Health
Author / Creator: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.
Publisher:Hoboken, USA: John Wiley & Sons, Inc
Journal title:The oncologist (Dayton, Ohio), 2021-10, Vol.26 (10), p.e1786-e1799
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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 da...
Author / Creator:Fallah, Jaleh, MD ; Zhang, Lijun, PhD ; Amatya, Anup, PhD ; Gong, Yutao, PhD ; King-Kallimanis, Bellinda, PhD ; Bhatnagar, Vishal, MD ; Weinstock, Chana, MD ; Suzman, Daniel L, MD ; Agrawal, Sundeep, MD ; Chang, Elaine, MD ; Anscher, Mitchell S, MD ; Chi, Dow-Chung, MD ; Xu, James X, MD ; Brewer, Jamie R, MD ; Brave, Michael H, MD ; Hadadi, Mehrnoosh, MD ; Theoret, Marc R, MD ; Kluetz, Paul G, MD ; Goldberg, Kirsten B, MA ; Ibrahim, Amna, MD ; Tang, Shenghui, PhD ; Pazdur, Richard, MD ; Beaver, Julia A, MD ; Amiri-Kordestani, Laleh, MD ; Singh, Harpreet, MD
Publisher:London: Elsevier Ltd
Journal title:The lancet oncology, 2021-09, Vol.22 (9), p.1230-1239
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FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum‐Based Chemotherapy in Extensive Stage Small Cell Lung Cancer
Author / Creator:Mathieu, Luckson ; Shah, Sujay ; Pai‐Scherf, Lee ; Larkins, Erin ; Vallejo, Jonathon ; Li, Xiaoxue ; Rodriguez, Lisa ; Mishra‐Kalyani, Pallavi ; Goldberg, Kirsten B. ; Kluetz, Paul G. ; Theoret, Marc R. ; Beaver, Julia A. ; Pazdur, Richard ; Singh, Harpreet
Publisher:Hoboken, USA: John Wiley & Sons, Inc
Journal title:The oncologist (Dayton, Ohio), 2021-05, Vol.26 (5), p.433-438
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ArticlesPeer ReviewedFull Text
FDA Approval Summary: Nivolumab Plus Ipilimumab for the Treatment of Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib
Author / Creator:Saung, May Tun ; Pelosof, Lorraine ; Casak, Sandra ; Donoghue, Martha ; Lemery, Steven ; Yuan, Mengdie ; Rodriguez, Lisa ; Schotland, Peter ; Chuk, Meredith ; Davis, Gina ; Goldberg, Kirsten B. ; Theoret, Marc R. ; Pazdur, Richard ; Fashoyin‐Aje, Lola
Publisher:Hoboken, USA: John Wiley & Sons, Inc
Journal title:The oncologist (Dayton, Ohio), 2021-09, Vol.26 (9), p.797-806
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ArticlesPeer ReviewedFull Text
Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis
Author / Creator:Beaver, Julia A ; Hazarika, Maitreyee ; Mulkey, Flora ; Mushti, Sirisha ; Chen, Huanyu ; He, Kun ; Sridhara, Rajeshwari ; Goldberg, Kirsten B ; Chuk, Meredith K ; Chi, Dow-Chung ; Chang, Jennie ; Barone, Amy ; Balasubramaniam, Sanjeeve ; Blumenthal, Gideon M ; Keegan, Patricia ; Pazdur, Richard ; Theoret, Marc R
Publisher:England: Elsevier Ltd
Journal title:The lancet oncology, 2018-02, Vol.19 (2), p.229-239
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ArticlesPeer ReviewedFull Text
Oncology Expanded Access and FDA's Project Facilitate
Author / Creator:Scepura, Barbara ; Chan, Mitchell ; Kim, Tamy ; Boehmer, Jessica ; Goldberg, Kirsten B. ; Pazdur, Richard
Publisher:Hoboken, USA: John Wiley & Sons, Inc
Journal title:The oncologist (Dayton, Ohio), 2021-10, Vol.26 (10), p.e1880-e1882
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ArticlesPeer ReviewedFull Text
FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA‐Mutated Metastatic Castrate‐Resistant Prostate Cancer
Author / Creator:Anscher, Mitchell S. ; Chang, Elaine ; Gao, Xin ; Gong, Yutao ; Weinstock, Chana ; Bloomquist, Erik ; Adeniyi, Oluseyi ; Charlab, Rosane ; Zimmerman, Sarah ; Serlemitsos‐Day, Maritsa ; Ning, Yang Min ; Mayrosh, Ruth ; Fuller, Barbara ; Trentacosti, Ann Marie ; Gallagher, Pamela ; Bijwaard, Karen ; Philip, Reena ; Ghosh, Soma ; Fahnbulleh, Frances ; Diggs, Felicia ; Arora, Shaily ; Goldberg, Kirsten B. ; Tang, Shenghui ; Amiri‐Kordestani, Laleh ; Pazdur, Richard ; Ibrahim, Amna ; Beaver, Julia A.
Publisher:Hoboken, USA: John Wiley & Sons, Inc
Journal title:The oncologist (Dayton, Ohio), 2021-02, Vol.26 (2), p.139-146
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ArticlesPeer ReviewedFull Text
FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy
Author / Creator:Le, Robert Q ; Wang, Xin ; Zhang, Hongfei ; Li, Hongshan ; Przepiorka, Donna ; Vallejo, Jonathon ; Leong, Ruby ; Ma, Lian ; Goldberg, Kirsten B ; Pazdur, Richard ; Theoret, Marc R ; De Claro, Angelo
Publisher:US: Oxford University Press
Journal title:The oncologist (Dayton, Ohio), 2022-06, Vol.27 (6), p.493-500
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ArticlesPeer ReviewedFull Text
Benefit–Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine‐ and Platinum‐Based...
Author / Creator:Pelosof, Lorraine ; Saung, May Tun ; Donoghue, Martha ; Casak, Sandra ; Mushti, Sirisha ; Cheng, Joyce ; Jiang, Xiling ; Liu, Jiang ; Zhao, Hong ; Khazraee, Maryam ; Goldberg, Kirsten B. ; Theoret, Marc ; Lemery, Steven ; Pazdur, Richard ; Fashoyin‐Aje, Lola
Publisher:Hoboken, USA: John Wiley & Sons, Inc
Journal title:The oncologist (Dayton, Ohio), 2021-04, Vol.26 (4), p.318-324
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ArticlesPeer ReviewedFull Text
Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy
Author / Creator:Mushti, Sirisha L. ; Mulkey, Flora ; Tang, Shenghui ; Singh, Harpreet ; Lemery, Steven J. ; Goldberg, Kirsten B. ; Sridhara, Rajeshwari ; Keegan, Patricia ; Kluetz, Paul G. ; Pazdur, Richard ; Theoret, Marc R. ; Beaver, Julia A.
Publisher:New York: Springer US
Journal title:Current oncology reports, 2020-11, Vol.22 (11), p.116-116, Article 116
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ArticlesPeer ReviewedFull Text
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 / Creator: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 ; Galsky, Matthew D.
Publisher:London: Nature Publishing Group UK
Journal title:Nature reviews. Urology, 2022-01, Vol.19 (1), p.37-46
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ArticlesPeer ReviewedFull Text
An FDA Pooled Analysis of Patients with Melanoma Treated with an Anti-PD1 Antibody Beyond RECIST Progression
Author / Creator:Beaver, Julia A. ; Hazarika, Maitreyee ; Mulkey, Flora ; Mushti, Sirisha ; Chen, Huanyu ; He, Kun ; Sridhara, Rajeshwari ; Goldberg, Kirsten B. ; Chuk, Meredith K. ; Chi, Dow-Chung ; Chang, Jennie ; Barone, Amy ; Balasubramaniam, Sanjeeve ; Blumenthal, Gideon M. ; Keegan, Patricia ; Pazdur, Richard ; Theoret, Marc R.
Journal title:The lancet oncology, 2018-01, Vol.19 (2), p.229-239
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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

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Systematic Review of PD‐1/PD‐L1 Inhibitors in Oncology: From Personalized Medicine to Public Health

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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 da...

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FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum‐Based Chemotherapy in Extensive Stage Small Cell Lung Cancer

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FDA Approval Summary: Nivolumab Plus Ipilimumab for the Treatment of Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib

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Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis

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Oncology Expanded Access and FDA's Project Facilitate

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FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA‐Mutated Metastatic Castrate‐Resistant Prostate Cancer

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FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy

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Benefit–Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine‐ and Platinum‐Based...

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Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy

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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

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An FDA Pooled Analysis of Patients with Melanoma Treated with an Anti-PD1 Antibody Beyond RECIST Progression

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