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Dianne Spillman
Dianne Spillman
Food and Drug Administration
Oncology
Internal medicine
Medicine
fda approval
Lung cancer
5
Papers
30
Citations
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FDA Approval Summary: Osimertinib for adjuvant treatment of surgically resected non-small cell lung cancer, a collaborative Project Orbis review.
2021
Clinical Cancer Research
Abigail L. Koch
Paz J. Vellanki
Nicole Drezner
Xiaoxue Li
Pallavi Shruti Mishra-Kalyani
Yuan-Li Shen
Huiming Xia
Yangbing Li
Jiang Liu
Jeanne Fourie Zirkelbach
Elitza Palazov
Aleksandr Gamarian
Qiuyi Choo
Arūnas Girčys
Ulrich-Peter Rohr
Nataliya Fesenko
Dianne Spillman
Richard Pazdur
Julia A. Beaver
Harpreet Singh
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FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-Small Cell Lung Cancer, a Collaborative Project Orbis Review.
2021
Clinical Cancer Research
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
Victoria Mansell
Kwadwo Korsah
Dianne Spillman
R. Angelo de Claro
Richard Pazdur
Julia A. Beaver
Harpreet Singh
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Citations (3)
FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis.
2020
Clinical Cancer Research
Shaily Arora
Sanjeeve Balasubramaniam
Wei Zhang
Lijun Zhang
Rajeshwari Sridhara
Dianne Spillman
Jaigi P Mathai
Bradley Scott
Sarah J Golding
Michael Coory
Richard Pazdur
Julia A. Beaver
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Citations (22)
Project Orbis: Global Collaborative Review Program.
2020
Clinical Cancer Research
R. Angelo de Claro
Dianne Spillman
Lauren Tesh Hotaki
Michael Shum
Laila Sofia Mouawad
Gustavo Mendes Lima Santos
Kelly Robinson
Melissa Hunt
Caroline Healy
Agnes Chan
Yee Hoo Looi
Clare Rodrigues
Ulrich-Peter Rohr
Chantal Walther
Richard Pazdur
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Citations (4)
FDA’s Oncology Center for Excellence Pilots Project Orbis: A framework for concurrent submission and review of oncology products among international partners.
2020
Journal of Clinical Oncology
Dianne Spillman
Shaily Arora
Rajesh Venugopal
Bradley Scott
Sarah J Golding
Nicholas Richardson
Yvette L. Kasamon
Jean-Francois Ethier
Kate Gurd
Harpreet Singh
R. Angelo DeClaro
Julia A. Beaver
Tamy Kim
Kirsten B. Goldberg
Paul G. Kluetz
Marc Robert Theoret
Richard Pazdur
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