Showing 1 - 20 results of 74 for search '"De Claro RA"', query time: 1.54s Refine Results
1
Academic Journal

Authors: Gong X; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Hu M; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Liu J; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Kim G; BeiGene, Cambridge, MA, USA., Xu J; Potomac Oncology and Hematology, Rockville, MD, USA., McKee A; Parexel, Washington, DC, USA., Palmby T; BeiGene, Cambridge, MA, USA., de Claro RA; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Zhao L; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Liang.Zhao@fda.hhs.gov.

Source: Nature communications [Nat Commun] 2022 Jul 27; Vol. 13 (1), pp. 4349. Date of Electronic Publication: 2022 Jul 27.

Publication Type: Journal Article

Journal Info: Publisher: Nature Pub. Group Country of Publication: England NLM ID: 101528555 Publication Model: Electronic Cited Medium: Internet ISSN: 2041-1723 (Electronic) Linking ISSN: 20411723 NLM ISO Abbreviation: Nat Commun Subsets: PubMed not MEDLINE; MEDLINE

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2
Academic Journal

Authors: Sekeres MA; Sylvester Comprehensive Cancer Center, Miami, FL, United States., Kim N; United States Food and Drug Administration, Silver Spring, MD, United States., DeZern AE; Sidney Kimmel Cancer Center, Baltimore, MD, United States., Norsworthy KJ; United States Food and Drug Administration, Silver Spring, MD, United States., Garcia JS; Dana-Farber Cancer Institute, Boston, MA, United States., de Claro RA; United States Food and Drug Administration, Silver Spring, MD, United States., Theoret MR; Food and Drug Administration, Silver Spring, MD, United States., Jen EY; United States Food and Drug Administration, Silver Spring, MD, United States., Ehrlich LA; United States Food and Drug Administration, Silver Spring, MD, United States., Zeidan AM; Yale University and Yale Cancer Center, New Haven, CT, United States., Komrokji RS; Moffitt Cancer Center, Tampa, FL, United States.

Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2023 Jan 23. Date of Electronic Publication: 2023 Jan 23.

Publication Type: Journal Article

Journal Info: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

3
Academic Journal

Authors: Pulte ED; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Chen H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Price LSL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Gudi R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Li H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Okusanya OO; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Ma L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Rodriguez L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Vallejo J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Norsworthy KJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., de Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Theoret MR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, USA., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Source: The oncologist [Oncologist] 2022 Mar 04; Vol. 27 (2), pp. 149-157.

Publication Type: Journal Article

Journal Info: Publisher: Oxford University Press Country of Publication: England NLM ID: 9607837 Publication Model: Print Cited Medium: Internet ISSN: 1549-490X (Electronic) Linking ISSN: 10837159 NLM ISO Abbreviation: Oncologist Subsets: MEDLINE

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4
Academic Journal

Authors: Agrawal S; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Arora S; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., de Claro RA; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Fashoyin-Aje L; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Gormley N; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Kim T; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland., Lemery S; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Mehta GU; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Scott EC; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Singh H; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Theoret MR; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland., Kluetz PG; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.

Source: JAMA oncology [JAMA Oncol] 2022 Dec 29. Date of Electronic Publication: 2022 Dec 29.

Publication Type: Journal Article

Journal Info: Publisher: American Medical Association Country of Publication: United States NLM ID: 101652861 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2374-2445 (Electronic) Linking ISSN: 23742437 NLM ISO Abbreviation: JAMA Oncol Subsets: MEDLINE

5
Academic Journal

Authors: Sweet KL; H. Lee Moffitt Cancer Center and Research Center, Tampa, FL, United States., Cortes JE; Augusta University, Augusta, SC, United States., Apperley JF; Imperial College London, London, United Kingdom., Mann M; Patient Advocate, Jonesboro, Georgia, United States., Mauro MJ; Memorial Sloan Kettering Cancer Center., Oehler VG; Fred Hutchinson Cancer Research Center, Seattle, WA, United States., Ruiz C; Patient Advocate, United States., Schiffer CA; Barbara Ann Karmanos Cancer Institute, Detroit, MI, United States., Ehrlich LA; United States Food and Drug Administration, Silver Spring, MD, United States., Pamuk GE; United States Food and Drug Administration, Silver Spring, MD, United States., Wynne J; United States Food and Drug Administration, Silver Spring, MD, United States., Mehta GU; United States Food and Drug Administration, Silver Spring, Maryland, United States., de Claro RA; United States Food and Drug Administration, Silver Spring, MD, United States., Theoret MR; Food and Drug Administration, Silver Spring, MD, United States., Smith BD; Johns Hopkins University, Baltimore, Maryland, United States., Norsworthy KJ; United States Food and Drug Administration, Silver Spring, MD, United States.

Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Dec 22. Date of Electronic Publication: 2022 Dec 22.

Publication Type: Journal Article

Journal Info: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

6
Academic Journal

Authors: Kim N; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Norsworthy KJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Subramaniam S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chen H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Manning ML; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Kitabi E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Earp J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ehrlich LA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Okusanya OO; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Vallejo J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gehrke BJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., de Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Aug 15; Vol. 28 (16), pp. 3411-3416.

Publication Type: Clinical Trial, Phase II; Journal Article

Journal Info: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

7
Academic Journal

Authors: Jen EY; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Wang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Lee SL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ni N; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Przepiorka D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Vallejo J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Leong R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ma L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gehrke BJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., McLamore S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Theoret MR; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., de Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Jul 15; Vol. 28 (14), pp. 2989-2993.

Publication Type: Journal Article; Randomized Controlled Trial

Journal Info: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

8
Academic Journal

Authors: Stewart MD; Friends of Cancer Research. Electronic address: mstewart@focr.org., McCall B; Genentech, A Member of the Roche Group., Pasquini M; Medical College of Wisconsin, Center for International Blood and Marrow Transplant Research., Yang AS; Xencor., Britten CD; Amgen., Chuk M; Food and Drug Administration., De Claro RA; Food and Drug Administration., George B; Food and Drug Administration., Gormley N; Food and Drug Administration., Horowitz MM; Medical College of Wisconsin, Center for International Blood and Marrow Transplant Research., Kowack E; Xencor., McCoy C; Bristol Myers Squibb., Morrow PK; Amgen., Okoye E; Regeneron Pharmaceuticals., Ricafort R; Bristol Myers Squibb., Rossi J; CERo Therapeutics., Sharon E; National Cancer Institute., Theoret M; Food and Drug Administration., Vegni F; Bristol Myers Squibb., Yu T; Amgen., Allen J; Friends of Cancer Research.

Source: Cytotherapy [Cytotherapy] 2022 Jul; Vol. 24 (7), pp. 742-749. Date of Electronic Publication: 2022 Feb 23.

Publication Type: Journal Article

Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 100895309 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1477-2566 (Electronic) Linking ISSN: 14653249 NLM ISO Abbreviation: Cytotherapy Subsets: MEDLINE

9
Academic Journal

Authors: Przepiorka D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Le RQ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ionan A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li RJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Wang YH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gudi R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Mitra S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Vallejo J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Okusanya OO; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ma L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yang Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Patel P; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Mezaache D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Shah R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Banerjee A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., McLamore S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Maung AN; Oncology Center of Excellence Summer Scholars Program, U.S. Food and Drug Administration, Silver Spring, Maryland., Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Theoret MR; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., De Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Jun 13; Vol. 28 (12), pp. 2488-2492.

Publication Type: Journal Article

Journal Info: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

10
Academic Journal

Authors: Thanarajasingam G; Division of Haematology, Mayo Clinic, Rochester, MN, USA. Electronic address: thanarajasingam.gita@mayo.edu., Minasian LM; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Bhatnagar V; Oncology Center for Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Cavalli F; Oncology Institute of Southern Switzerland, Bellinzona, Switzerland., De Claro RA; Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA., Dueck AC; Division of Quantitative Health Sciences Research, Mayo Clinic Arizona, Scottsdale, AZ, USA., El-Galaly TC; Department of Haematology, Clinical Cancer Research Center, Aalborg University Hospital, Aalborg, Denmark., Everest N; Health Resourcing Group, Australian Government Department of Health, Canberra, ACT, Australia., Geissler J; Leukaemia Patient Advocates Foundation, Bern, Switzerland., Gisselbrecht C; Haemato-Oncology Department, Hopital Saint-Louis, Institute Haematology, Paris Diderot University VII, Paris, France; European Medicines Agency, London, UK., Gormley N; Office of Oncologic Diseases, US Food and Drug Administration, Silver Spring, MD, USA., Gribben J; Centre for Haemato-Oncology, Barts Cancer Institute, London, UK., Horowitz M; Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI, USA., Ivy SP; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Jacobson CA; Dana-Farber Cancer Institute, Boston, MA, USA., Keating A; Princess Margaret Cancer Center, Toronto, ON, Canada., Kluetz PG; Oncology Center for Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Kwong YL; Department of Haematology and Haematologic Oncology, University of Hong Kong, Hong Kong Special Administrative Region, China., Little RF; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Matasar MJ; Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Mateos MV; Haematology Department, University Hospital of Salamanca-IBSAL, Salamanca, Spain., McCullough K; Division of Haematology, Mayo Clinic, Rochester, MN, USA., Miller RS; CancerLinQ, American Society of Clinical Oncology, Alexandria, VA, USA., Mohty M; Haematology and Cellular Therapy Department, Sorbonne University, Saint-Antoine Hospital (AP-HP), INSERM UMRs 938, Paris, France., Moreau P; Department of Haematology, University Hospital Nantes, Nantes, France., Morton LM; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Nagai S; Department of Medical Development, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Nair A; Oncology Center for Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Nastoupil L; University of Texas MD Anderson Cancer Center, Houston, TX, USA., Robertson K; Office of Product Review, Therapeutic Goods Administration, Canberra, ACT, Australia., Sidana S; Division of BMT and Cellular Therapy, Stanford University School of Medicine, Stanford, CA, USA., Smedby KE; Department of Medicine Solna, Division of Clinical Epidemiology, Karolinska Institutet, Stockholm, Sweden; Department of Haematology, Karolinska University Hospital, Stockholm, Sweden., Sonneveld P; Department of Haematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands., Tzogani K; European Medicines Agency, London, UK., van Leeuwen FE; Netherlands Cancer Institute, Amsterdam, Netherlands., Velikova G; Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK., Villa D; BC Cancer Centre for Lymphoid Cancer and University of British Columbia, Vancouver, BC, Canada., Wingard JR; Division of Haematology & Oncology, University of Florida College of Medicine, Gainesville, FL, USA., Seymour JF; Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Royal Melbourne Hospital, Melbourne, VIC, Australia; University of Melbourne, Melbourne, VIC, Australia., Habermann TM; Division of Haematology, Mayo Clinic, Rochester, MN, USA.

Source: The Lancet. Haematology [Lancet Haematol] 2022 May; Vol. 9 (5), pp. e374-e384.

Publication Type: Journal Article; Review

Journal Info: Publisher: Elsevier Ltd Country of Publication: England NLM ID: 101643584 Publication Model: Print Cited Medium: Internet ISSN: 2352-3026 (Electronic) Linking ISSN: 23523026 NLM ISO Abbreviation: Lancet Haematol Subsets: MEDLINE

11
Academic Journal

Authors: Li BT; Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine, New York, NY, USA. lib1@mskcc.org., Daly B; Memorial Sloan Kettering Cancer Center, Weill Cornell Medicine, New York, NY, USA., Gospodarowicz M; Princess Margaret Cancer Center, , University of Toronto, Toronto, Ontario, Canada., Bertagnolli MM; Dana-Farber Brigham Cancer Center, Harvard Medical School, Boston, MA, USA., Brawley OW; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Chabner BA; Massachusetts General Hospital Cancer Center, Boston, MA, USA.; Society for Translational Oncology, Durham, NC, USA., Fashoyin-Aje L; Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD, USA., de Claro RA; Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD, USA., Franklin E; Cancer Support Community, Washington, DC, USA., Mills J; Foundation Medicine, Inc., Cambridge, MA, USA., Legos J; Novartis, Basel, Switzerland., Kaucic K; PPD, Inc., Wilmington, NC, USA., Li M; Resolution Bioscience, Agilent Technologies, Kirkland, WA, USA., The L; McKinsey Cancer Center, McKinsey & Company., Hou T; McKinsey Cancer Center, McKinsey & Company., Wu TH; McKinsey Cancer Center, McKinsey & Company., Albrecht B; McKinsey Cancer Center, McKinsey & Company., Shao Y; McKinsey Cancer Center, McKinsey & Company., Finnegan J; Bloomberg New Economy, Bloomberg L.P., New York, NY, USA., Qian J; Asia Society Policy Institute, Asia Society, New York, NY, USA., Shahidi J; Daiichi Sankyo, Tokyo, Japan., Gasal E; Innovent Biologics, Suzhou, China., Tendler C; Janssen, Johnson and Johnson, New Brunswick, NJ, USA., Kim G; BeiGene USA, BeiGene, Beijing, China., Yan J; Zai Lab, Shanghai, China., Morrow PK; Amgen, Inc, Thousand Oaks, CA, USA., Fuchs CS; Genentech, South San Francisco, CA, USA.; Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA., Zhang L; Jiangsu Hengrui Pharmaceuticals, Shanghai, China., LaCaze R; Bayer AG, Leverkusen, Germany., Oelrich S; Bayer AG, Leverkusen, Germany., Murphy MJ; Society for Translational Oncology, Durham, NC, USA.; Shanghai TuoXin Health Promotion Center, Shanghai, China.; CEO Roundtable on Cancer, Morrisville, NC, USA., Pazdur R; Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD, USA., Rudd K; Asia Society Policy Institute, Asia Society, New York, NY, USA., Wu YL; Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Chinese Thoracic Oncology Group, Guangzhou, China.

Source: Nature medicine [Nat Med] 2022 Apr; Vol. 28 (4), pp. 620-626.

Publication Type: Journal Article

Journal Info: Publisher: Nature Publishing Company Country of Publication: United States NLM ID: 9502015 Publication Model: Print Cited Medium: Internet ISSN: 1546-170X (Electronic) Linking ISSN: 10788956 NLM ISO Abbreviation: Nat Med Subsets: MEDLINE

12
Academic Journal

Authors: Norsworthy KJ; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Gao X; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Ko CW; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Pulte ED; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Zhou J; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Gong Y; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Shen YL; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Vallejo J; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Gwise TE; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Sridhara R; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD., Deisseroth AB; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Farrell AT; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., de Claro RA; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Blumenthal GM; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD., Pazdur R; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD.

Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2022 Mar 10; Vol. 40 (8), pp. 847-854. Date of Electronic Publication: 2021 Dec 10.

Publication Type: Journal Article

Journal Info: Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE

13
Academic Journal

Authors: Mehta GU; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., de Claro RA; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.

Source: JAMA oncology [JAMA Oncol] 2022 Mar 01; Vol. 8 (3), pp. 335-336.

Publication Type: Journal Article

Journal Info: Publisher: American Medical Association Country of Publication: United States NLM ID: 101652861 Publication Model: Print Cited Medium: Internet ISSN: 2374-2445 (Electronic) Linking ISSN: 23742437 NLM ISO Abbreviation: JAMA Oncol Subsets: MEDLINE

14
Academic Journal

Authors: Pollyea DA; Division of Hematology, University of Colorado School of Medicine, Aurora, Colorado., Barrett J; George Washington Cancer Center, GW School of Medicine and Health Sciences, Washington, DC., DiNardo CD; Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas., Michaelis LC; Medical College of Wisconsin, Milwaukee, Wisconsin., Roboz GJ; Weill Cornell Medical College and the New York Presbyterian Hospital, New York, New York., Le RQ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC., Norsworthy KJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC., de Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Washington, DC., Theoret MR; Oncology Center of Excellence, U.S. Food and Drug Administration, Washington, DC., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Washington, DC.

Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Mar 01; Vol. 28 (5), pp. 816-820.

Publication Type: Journal Article

Journal Info: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

15
Academic Journal

Authors: Merino M; Office of Oncologic Diseases and Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland., Richardson N; Office of Oncologic Diseases and Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland., Reaman G; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Ande A; Office of Oncologic Diseases and Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland., Zvada S; Office of Oncologic Diseases and Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland., Liu C; Office of Oncologic Diseases and Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland., Hariharan S; Office of Oncologic Diseases and Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland., De Claro RA; Office of Oncologic Diseases and Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland., Farrell A; Office of Cardiology, Hematology, Endocrinology, and Nephrology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Office of Oncologic Diseases and Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

Source: Pediatric blood & cancer [Pediatr Blood Cancer] 2020 Dec; Vol. 67 (12), pp. e28688. Date of Electronic Publication: 2020 Sep 08.

Publication Type: Journal Article; Multicenter Study

Journal Info: Publisher: John Wiley Country of Publication: United States NLM ID: 101186624 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1545-5017 (Electronic) Linking ISSN: 15455009 NLM ISO Abbreviation: Pediatr Blood Cancer Subsets: MEDLINE

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16
Academic Journal

Authors: Ye J; Division of Biometrics V, Office of Biostatistics, Office of Translational Sciences, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Reaman G; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., De Claro RA; Division of Hematologic Malignancies 1 (DHM1), Office of Oncologic Diseases, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Sridhara R; Division of Biometrics V, Office of Biostatistics, Office of Translational Sciences, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Source: Pharmaceutical statistics [Pharm Stat] 2020 Nov; Vol. 19 (6), pp. 814-826. Date of Electronic Publication: 2020 Jun 14.

Publication Type: Journal Article

Journal Info: Publisher: Wiley Country of Publication: England NLM ID: 101201192 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1539-1612 (Electronic) Linking ISSN: 15391604 NLM ISO Abbreviation: Pharm Stat Subsets: MEDLINE

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17
Academic Journal

Authors: King-Kallimanis BL; Oncology Center of Excellence, U.S. Food and Drug Administration, Building 22, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. belinda.kallimanis@fda.hhs.gov.; U.S. Food and Drug Administration, WO22 Room 2372, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. belinda.kallimanis@fda.hhs.gov., Wroblewski T; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA., Kwitkowski V; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA., De Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA., Gwise T; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA., Bhatnagar V; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA., Farrell AT; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA., Kluetz PG; Oncology Center of Excellence, U.S. Food and Drug Administration, Building 22, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

Source: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation [Qual Life Res] 2020 Jul; Vol. 29 (7), pp. 1903-1911. Date of Electronic Publication: 2020 Feb 25.

Publication Type: Journal Article

Journal Info: Publisher: Springer Netherlands Country of Publication: Netherlands NLM ID: 9210257 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-2649 (Electronic) Linking ISSN: 09629343 NLM ISO Abbreviation: Qual Life Res Subsets: MEDLINE

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18
Academic Journal

Authors: Amatya AK; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Biostatistics, Silver Spring, Maryland. anup.amatya@fda.hhs.gov., Fiero MH; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Biostatistics, Silver Spring, Maryland., Bloomquist EW; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Biostatistics, Silver Spring, Maryland., Sinha AK; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Biostatistics, Silver Spring, Maryland., Lemery SJ; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Singh H; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Ibrahim A; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Donoghue M; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Fashoyin-Aje LA; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., de Claro RA; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Gormley NJ; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Amiri-Kordestani L; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Sridhara R; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Theoret MR; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Kluetz PG; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Pazdur R; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Beaver JA; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Oncologic Diseases, Silver Spring, Maryland.; US Food and Drug Administration, Oncology Center of Excellence, Silver Spring, Maryland., Tang S; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Biostatistics, Silver Spring, Maryland.

Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 Nov 01; Vol. 27 (21), pp. 5753-5756. Date of Electronic Publication: 2021 Jun 11.

Publication Type: Journal Article; Review

Journal Info: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

19
Academic Journal

Authors: Pulte ED; Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland. Elizabeth.pulte@fda.hhs.gov., Norsworthy KJ; Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland., Wang Y; Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland., Xu Q; Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland., Qosa H; Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland., Gudi R; Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland., Przepiorka D; Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland., Fu W; Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland., Okusanya OO; Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland., Goldberg KB; Oncology Center of Excellence, FDA, Silver Spring, Maryland., De Claro RA; Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland., Farrell AT; Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, FDA, Silver Spring, Maryland.

Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 Jul 01; Vol. 27 (13), pp. 3515-3521. Date of Electronic Publication: 2021 Feb 25.

Publication Type: Journal Article; Randomized Controlled Trial

Journal Info: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE

20
Academic Journal

Authors: Vellanki PJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. paz.vellanki@fda.hhs.gov., Mulkey F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Jaigirdar AA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Rodriguez L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Wang Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Xu Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhao H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Liu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Howe G; Health Canada, Ottawa, Ontario, Canada., Wang J; Health Canada, Ottawa, Ontario, Canada., Choo Q; Health Sciences Authority, Singapore, Republic of Singapore., Golding SJ; Therapeutic Goods Administration, Canberra, Australia., Mansell V; Therapeutic Goods Administration, Canberra, Australia., Korsah K; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Spillman D; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., de Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Singh H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2021 Jul 01; Vol. 27 (13), pp. 3522-3527. Date of Electronic Publication: 2021 Feb 25.

Publication Type: Journal Article; Randomized Controlled Trial

Journal Info: Publisher: The Association Country of Publication: United States NLM ID: 9502500 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE