RomeoAngeloDe ClaroMD

PubMed

• 3 citations
  Considerations for Drug Development in Myelodysplastic Syndromes.
  Mikkael A Sekeres, Nina Kim, Amy E DeZern, Kelly J Norsworthy, Jacqueline S Garcia, R Angelo de Claro, Marc R Theoret, Emily Y Jen, Lori A Ehrlich, Amer M Zeidan, Rami...> ;Clinical Cancer Research. 2023 Jul 14
• 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
• 2 citations
  Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia.
  Kendra L Sweet, Jorge E Cortes, Jane F Apperley, Mel Mann, Michael J Mauro, Vivian G Oehler, Cristina Ruiz, Charles A Schiffer, Lori A Ehrlich, Gulsum E Pamuk, Joseph ...> ;Clinical Cancer Research. 2023 Jun 13
• 5 citations
  FDA Approval Summary: Oral Azacitidine for Continued Treatment of Adults with Acute Myeloid Leukemia Unable to Complete Intensive Curative Therapy.
  Emily Y Jen, Xin Wang, Meng Li, Hongshan Li, Shwu-Luan Lee, Nina Ni, Donna Przepiorka, Jonathon Vallejo, Ruby Leong, Lian Ma, Brenda J Gehrke, Sherita McLamore, Marc R...> ;Clinical Cancer Research. 2022 Jul 15
• 8 citations
  FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy.
  Donna Przepiorka, Robert Q Le, Alexei Ionan, Ruo-Jing Li, Ying-Hong Wang, Ramadevi Gudi, Soumya Mitra, Jonathon Vallejo, Olanrewaju O Okusanya, Lian Ma, Yuching Yang, ...> ;Clinical Cancer Research. 2022 Jun 13
• 7 citations
  Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies.
  Gita Thanarajasingam, Lori M Minasian, Vishal Bhatnagar, Franco Cavalli, R Angelo De Claro, Amylou C Dueck, Tarec C El-Galaly, Neil Everest, Jan Geissler, Christian Gi...> ;The Lancet. Haematology. 2022 May 1
• 11 citations
  FDA Approval Summary: Decitabine and Cedazuridine Tablets for Myelodysplastic Syndromes.
  Nina Kim, Kelly J Norsworthy, Sriram Subramaniam, Haiyan Chen, Michael L Manning, Eliford Kitabi, Justin Earp, Lori A Ehrlich, Olanrewaju O Okusanya, Jonathon Vallejo,...> ;Clinical Cancer Research. 2022 Aug 15
• 13 citations
  Reimagining patient-centric cancer clinical trials: a multi-stakeholder international coalition.
  Bob T Li, Bobby Daly, Mary Gospodarowicz, Monica M Bertagnolli, Otis W Brawley, Bruce A Chabner, Lola Fashoyin-Aje, R Angelo de Claro, Elizabeth Franklin, Jennifer Mil...> ;Nature Medicine. 2022 Apr 1
• 13 citations
  Response Rate, Event-Free Survival, and Overall Survival in Newly Diagnosed Acute Myeloid Leukemia: US Food and Drug Administration Trial-Level and Patient-Level Analy...
  Kelly J Norsworthy, Xin Gao, Chia-Wen Ko, E Dianne Pulte, Jiaxi Zhou, Yutao Gong, Yuan Li Shen, Jonathon Vallejo, Thomas E Gwise, Rajeshwari Sridhara, Albert B Deisser...> ;Journal of Clinical Oncology. 2022 Mar 10
• 4 citations
  FDA Approval Summary: Revised Indication and Dosing Regimen for Ponatinib Based on the Results of the OPTIC Trial.
  E Dianne Pulte, Haiyan Chen, Lauren S L Price, Ramadevi Gudi, Hongshan Li, Olanrewaju O Okusanya, Lian Ma, Lisa Rodriguez, Jonathon Vallejo, Kelly J Norsworthy, R Ange...> ;The Oncologist. 2022 Mar 4
• 15 citations
  Accelerated Approval Is Not Conditional Approval: Insights From International Expedited Approval Programs.
  Gautam U Mehta, R Angelo de Claro, Richard Pazdur> ;JAMA Oncology. 2022 Mar 1
• 8 citations
  Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples.
  Anup K. Amatya, Mallorie H. Fiero, Erik Bloomquist, Arup K. Sinha, Steven Lemery, Harpreet Singh, Amna Ibrahim, Martha Donoghue, Lola Fashoyin-Aje, R. Angelo de Claro,...> ;Clinical Cancer Research. 2021 Jun 11
• 31 citations
  FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
  E. Dianne Pulte, Kelly J. Norsworthy, Yaping Wang, Qing Xu, Hisham Qosa, Ramadevi Gudi, Donna Przepiorka, Wentao Fu, Olanrewaju O. Okusanya, Kirsten B. Goldberg, R. An...> ;Clinical Cancer Research. 2021 Feb 25
• 25 citations
  FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non–small Cell Lung Cancer, A Collaborative Project Orbis Review
  Paz J. Vellanki, Flora Mulkey, Adnan A. Jaigirdar, Lisa Rodriguez, Yibo Wang, Yuan Xu, Hong Zhao, Jiang Liu, Grant Howe, Jian Wang, Qiuyi Choo, Sarah J. Golding, Victo...> ;Clinical Cancer Research. 2021 Feb 25
• 12 citations
  U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program.
  R. Angelo de Claro, Jennifer J Gao, Tamy Kim, Paul G. Kluetz, Marc R. Theoret, Julia A. Beaver, Richard Pazdur> ;Clinical Cancer Research. 2021 Jan 1
• 31 citations
  Project Orbis: Global Collaborative Review Program
  R. Angelo de Claro, Dianne Spillman, Lauren Tesh Hotaki, Michael Shum, Laila Sofia Mouawad, Gustavo Mendes Lima Santos, Kelly Robinson, Melissa Hunt, Caroline Healy, A...> ;Clinical Cancer Research. 2020 Dec 15
• 4 citations
  BCR-ABL1 tyrosine kinase inhibitor-associated thyroid dysfunction: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature
  Shital Patel, Afrouz Nayernama, Steven Christopher Jones, Romeo Angelo de Claro, Peter E. Waldron> ;American Journal of Hematology. 2020 Sep 30
• 140 citations
  FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma
  Najat Bouchkouj, Yvette L. Kasamon, R. Angelo de Claro, Bindu George, Xue Lin, Shiowjen Lee, Gideon M. Blumenthal, Wilson Bryan, Amy E. McKee, Richard Pazdur> ;Clinical Cancer Research. 2019 Mar 15
• FDA Approval Summary: Brentuximab Vedotin in First-Line Treatment of Peripheral T-Cell Lymphoma.
  Richardson, N. C.,Kasamon, Y. L.,Chen, H.,de Claro, R. A.,Ye, J.,Blumenthal, G. M.,Farrell, A. T.,Pazdur, R.> ;Oncologist. 2019 Mar 28
• 83 citations
  Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.
  Gita Thanarajasingam, Lori M. Minasian, Frédéric Baron, Franco Cavalli, R. Angelo de Claro, Amylou C. Dueck, Tarec Christoffer El-Galaly, Neil Everest, Jan Geissler, C...> ;The Lancet. Haematology. 2018 Nov 1
• Dose Finding in Late-Phase Drug Development.
  Nie, L.,Lee, K. Y.,Verdun, N.,De Claro, R. A.,Sridhara, R.> ;Ther Innov Regul Sci. 2018 Sep 19
• 87 citations
  FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia
  R. Angelo de Claro, Karen M. McGinn, Nicole Verdun, Shwu-Luan Lee, Haw-Jyh Chiu, Haleh Saber, Margaret E Brower, C.J. George Chang, Elimika Pfuma, Bahru A. Habtemariam...> ;Clinical Cancer Research. 2015 Aug 15
• U.S. Food and Drug Administration approval summary: brentuximab vedotin for the treatment of relapsed Hodgkin lymphoma or relapsed systemic anaplastic large-cell lymph...
  de Claro RA McGinn K Kwitkowski V Bullock J Khandelwal A Habtemariam B Ouyang Y Saber H Lee K Koti K Rothmann M Shapiro M Borrego F Clouse K Chen XH Bro...> ;Clin Cancer Res. 2012 Nov 1
• FDA Approval: Idelalisib Monotherapy for the Treatment of Patients with Follicular Lymphoma and Small Lymphocytic Lymphoma.
  Miller, B. W.,Przepiorka, D.,de Claro, R. A.,Lee, K.,Nie, L.,Simpson, N.,Gudi, R.,Saber, H.,Shord, S.,Bullock, J.,Marathe, D.,Mehrotra, N.,Hsieh, L. S.,Ghosh, D.,Brown...> ;Clin. Cancer Res.. 2015 Feb 04
• Hematopoietic Fas deficiency does not affect experimental atherosclerotic lesion formation despite inducing a proatherogenic state.
  de Claro, R. A., Zhu, X., Tang, J., Morgan-Stevenson, V., Schwartz, B. R., Iwata, A., Liles, W. C., Raines, E. W., Harlan, J. M.> ;Am J Pathol. 2011 Jun
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