RichardPazdurMD

PubMed

• FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation.
  Ashley Woods, Xin Wang, Jonathon Vallejo, Ruo-Jing Li, Jielin Sun, Rosane Charlab, Xiling Jiang, Marc R Theoret, R Angelo de Claro, Norsworthy, K. J., Norsworthy, K. J...> ;Clinical Cancer Research. 2024 Apr 1
• Remote Monitoring and Data Collection for Decentralized Clinical Trials.
  Bobby Daly, Otis W Brawley, Mary K Gospodarowicz, Olufunmilayo I Olopade, Lola Fashoyin-Aje, Victoria Wolodzko Smart, I-Fen Chang, Craig L Tendler, Geoffrey Kim, Charl...> ;JAMA Network Open. 2024 Apr 1
• US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Muta...
  Brian L Heiss, Elaine Chang, Xin Gao, Tien Truong, Michael H Brave, Erik Bloomquist, Ankit Shah, Salaheldin Hamed, Jeffrey Kraft, Haw-Jyh Chiu, Tiffany K Ricks, Amy Ti...> ;Journal of Clinical Oncology. 2024 Mar 7
• Correlations of response rate and progression-free survival with overall survival in immunotherapy trials for metastatic non-small-cell lung cancer: an FDA pooled anal...
  Bernardo Haddock Lobo Goulart, Sirisha L Mushti, Somak Chatterjee, Erin Larkins, Pallavi S Mishra-Kalyani, Richard Pazdur, Paul G Kluetz, Harpreet Singh> ;The Lancet. Oncology. 2024 Apr 1
• FDA approvals in 2023: biomarker-positive subsets, equipoise and verification of benefit.
  Norsworthy, K., Lee-Alonzo, R., Pazdur, R.> ;Nature Reviews. Clinical Oncology. 2024 Feb 21
• 3 citations
  FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma.
  Timil H Patel, Jamie R Brewer, Jiaxin Fan, Joyce Cheng, Yue Xiang, Hong Zhao, Steven J Lemery, Lola A Fashoyin-Aje, Shen, Y., Pazdur, R., Kluetz, P.> ;Clinical Cancer Research. 2024 Jan 17
• Review of Racial and Ethnic Representation of Participants Enrolled in Pediatric Clinical Trials of Oncology Drugs Conducted Through FDA Written Requests.
  Lola A Fashoyin-Aje, Alemayehu Y Akalu, Jessica Boehmer, Richard Pazdur, Martha Donoghue, Gregory H Reaman> ;JAMA Oncology. 2024 Mar 1
• FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.
  Christy L Osgood, Zhou Feng, Erik W Bloomquist, Shenghui Tang, C J George Chang, Tiffany K Ricks, Sherry C Hou, William F Pierce, Donna R Rivera, Laleh Amiri-Kordestan...> ;Clinical Cancer Research. 2023 Dec 15
• 1 citations
  FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrang...
  Shruti U Gandhy, Sandra J Casak, Sirisha L Mushti, Joyce Cheng, Sriram Subramaniam, Hong Zhao, Miao Zhao, Youwei Bi, Guansheng Liu, Jianghong Fan, Oluseyi Adeniyi, Ros...> ;Clinical Cancer Research. 2023 Oct 13
• 8 citations
  FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer.
  Asma Dilawari, Mirat Shah, Gwynn Ison, Haley Gittleman, Mallorie H Fiero, Ankit Shah, Salaheldin S Hamed, Junshan Qiu, Jingyu Yu, Wimolnut Manheng, Tiffany K Ricks, Ra...> ;Clinical Cancer Research. 2023 Oct 2
• FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinica...
  Julie A Schneider, Julia Eckstein, Kirsten B Goldberg, Mark C Ascione, Thamar Bailey, Kimberly Taylor, Aisha M Coffey, Darshini Satchi, Howard Philips, Rajeshwari Srid...> ;Clinical Cancer Research. 2023 Aug 15
• 6 citations
  Eligibility criteria and enrollment of a diverse racial and ethnic population in multiple myeloma clinical trials.
  Bindu Kanapuru, Laura L Fernandes, Andrea Baines, Rachel Ershler, Vishal Bhatnagar, Elizabeth Pulte, Thomas Gwise, Marc R Theoret, Richard Pazdur, Lola Fashoyin-Aje, N...> ;Blood. 2023 Jul 20
• Advancing Therapies for Asian Americans, Native Hawaiians, and Other Pacific Islanders With Cancer: OCE's Project ASIATICA.
  Jennifer J Gao, Richard Pazdur, Tamy Kim> ;JCO Oncology Practice. 2023 Sep 1
• 1 citations
  Driving Diversity and Inclusion in Cancer Drug Development - Industry and Regulatory Perspectives, Current Practices, Opportunities, and Challenges.
  Lola A Fashoyin-Aje, Craig Tendler, Bea Lavery, Serban Ghiorghiu, Brittany Gerald, Chitkala Kalidas, Nicole Richie, Kathleen Winson, Nicholas J H Warren, Tristen V Tel...> ;Clinical Cancer Research. 2023 Sep 15
• 30 citations
  Trends in the approval of cancer therapies by the FDA in the twenty-first century.
  Emma C Scott, Andrea C Baines, Yutao Gong, Rodney Moore Jr, Gulsum E Pamuk, Haleh Saber, Ashim Subedee, Matthew D Thompson, Wenming Xiao, Richard Pazdur, V Ashutosh Ra...> ;Nature Reviews. Drug Discovery. 2023 Aug 1
• 2 citations
  A U.S. Food and Drug Administration-pooled Analysis of Frontline Combination Treatment Survival Benefits by Risk Groups in Metastatic Renal Cell Carcinoma.
  Daniel Lee, Haley Gittleman, Chana Weinstock, Daniel Suzman, Erik Bloomquist, Sundeep Agrawal, Michael Brave, Jamie Brewer, Jaleh Fallah, Harpreet Singh, Shenghui Tang...> ;European Urology. 2023 Oct 1
• 9 citations
  Association between antibiotics and adverse oncological outcomes in patients receiving targeted or immune-based therapy for hepatocellular carcinoma.
  David J Pinato, Xiaoxue Li, Pallavi Mishra-Kalyani, Antonio D'Alessio, Claudia A M Fulgenzi, Bernhard Scheiner, Matthias Pinter, Guo Wei, Julie Schneider, Donna R Rive...> ;JHEP Reports. 2023 Jun 1
• 4 citations
  FDA Analysis of Ineligibility for Acute Myeloid Leukemia Clinical Trials by Race and Ethnicity.
  Dianne Pulte, Laura Fernandes, Guo Wei, Ashley Woods, Kelly J Norsworthy, Nicole Gormley, Bindu Kanapuru, Thomas E Gwise, Richard Pazdur, Julie Schneider, Marc R Theor...> ;Clinical Lymphoma, Myeloma & Leukemia. 2023 Jun 1
• 1 citations
  Approvals in 2022: overall survival, dose optimization, new approvals and beyond.
  Deepti Telaraja, Nicole Gormley, Richard Pazdur> ;Nature Reviews. Clinical Oncology. 2023 Apr 1
• 18 citations
  US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Ca...
  Preeti Narayan, Asma Dilawari, Christy Osgood, Zhou Feng, Erik Bloomquist, William F Pierce, Samina Jafri, Shyam Kalavar, Marina Kondratovich, Prakash Jha, Shenghui Ta...> ;Journal of Clinical Oncology. 2023 Apr 10
• 3 citations
  FDA Approval Summary: Belzutifan for VHL Disease Tumors-Response.
  Jaleh Fallah, Chana Weinstock, Gautam U Mehta, Michael H Brave, William F Pierce, Richard Pazdur, Abhilasha Nair, Daniel L Suzman, Laleh Amiri-Kordestani> ;Clinical Cancer Research. 2023 Feb 1
• 11 citations
  Regulatory implications of ctDNA in immuno-oncology for solid tumors.
  Paz J Vellanki, Anand Pathak, Michael J Fusco, Erik W Bloomquist, Shenghui Tang, Harpreet Singh, Reena Philip, Richard Pazdur, Julia A Beaver, Ghosh, S.> ;Journal for Immunotherapy of Cancer. 2023 Feb 1
• 9 citations
  FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
  Duke, E., Stapleford, L., Drezner, N., Amatya, A., Mishra-Kalyani, P., Shen, Y., Maxfield, K., Zirkelbach, J., Bi, Y., Liu, J., Zhang, X., Wang, H., Yang, Y., Zheng, N...> ;Clinical Cancer Research. 2023 Feb 1
• 12 citations
  Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021.
  Sundeep Agrawal, Shaily Arora, Laleh Amiri-Kordestani, R Angelo de Claro, Lola Fashoyin-Aje, Nicole Gormley, Tamy Kim, Steven Lemery, Gautam U Mehta, Emma C Scott, Har...> ;JAMA Oncology. 2023 Feb 1
• 1 citations
  FDA Approval Summary: Ripretinib for Advanced Gastrointestinal Stromal Tumor.
  Vaibhav Kumar, Leslie Doros, Margaret Thompson, Sirisha L Mushti, Rosane Charlab, Elizabeth I Spehalski, Hong Zhao, Matthew D Thompson, Shenghui Tang, Richard Pazdur, ...> ;Clinical Cancer Research. 2023 Jun 1
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Journal Articles

• Contribution of Early Clinical Benefit End Points to Decreased Lung Cancer Mortality Rates  
  Richard Pazdur, MD, JAMA Oncology
• Analysis of Time to Treatment Discontinuation of Targeted Therapy, Immunotherapy, and Chemotherapy in Clinical Trials of Patients with Non-Small Cell Lung Cancer  
  G R Oxnard, G M Blumenthal, P G Kluetz, R Pazdur, Annals of Oncology
• Metastasis-Free Survival — A New End Point in Prostate Cancer Trials  
  Richard Pazdur, MD, The New England Journal of Medicine

Abstracts/Posters

• US Food and Drug Administration Support for Oncology Drug Development During COVID-19
  Richard Pazdur, MD, JAMA Oncology, Orlando, FL, 12/8/2019