Search Results - "Gormley N"

Authors: Shah UA; Myeloma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA. shahu@mskcc.org.; Department of Medicine, Weill Cornell Medical College, 400 East 67th Street, New York, NY, 10065, USA. shahu@mskcc.org., Whiting K; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, 1275 York Avenue, New York, NY, 10065, USA., Devlin S; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, 1275 York Avenue, New York, NY, 10065, USA., Ershler R; Division of Hematologic Malignancies II, Center for Drug Evaluation and Research, U.S. Food, and Drug Administration, 5901-B Ammendale Road, Beltsville, MD, 20705-1266, USA., Kanapuru B; Division of Hematologic Malignancies II, Center for Drug Evaluation and Research, U.S. Food, and Drug Administration, 5901-B Ammendale Road, Beltsville, MD, 20705-1266, USA., Lee DJ; Department of Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, 02215, USA., Tahri S; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, 02215, USA.; Department of Hematology, Erasmus University Medical Center, 3000CA, Rotterdam, The Netherlands., Gwise T; Division of Biometrics IX, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 5901-B Ammendale Road, Beltsville, MD, 20705-1266, USA., Rustad EH; Department of Cancer Immunology, Institute for Cancer Research, Oslo University Hospital Radiumhospitalet, 0379, Oslo, Norway.; Department of Medicine, Lovisenberg Diaconal Hospital, 0456, Oslo, Norway., Mailankody S; Myeloma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.; Department of Medicine, Weill Cornell Medical College, 400 East 67th Street, New York, NY, 10065, USA., Lesokhin AM; Myeloma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.; Department of Medicine, Weill Cornell Medical College, 400 East 67th Street, New York, NY, 10065, USA., Kazandjian D; Department of Medicine, Sylvester Comprehensive Cancer Center at the University of Miami, 1475 NW 12th Avenue, Miami, FL, 33136, USA., Maura F; Department of Medicine, Sylvester Comprehensive Cancer Center at the University of Miami, 1475 NW 12th Avenue, Miami, FL, 33136, USA., Auclair D; Multiple Myeloma Research Foundation, 383 Main Avenue #5, Norwalk, CT, 06851, USA., Birmann BM; Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 181 Longwood Avenue, Boston, MA, 02115, USA., Usmani SZ; Myeloma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.; Department of Medicine, Weill Cornell Medical College, 400 East 67th Street, New York, NY, 10065, USA., Gormley N; Division of Hematologic Malignancies II, Center for Drug Evaluation and Research, U.S. Food, and Drug Administration, 5901-B Ammendale Road, Beltsville, MD, 20705-1266, USA., Marinac CR; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, 02215, USA.; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, USA., Landgren O; Department of Medicine, Sylvester Comprehensive Cancer Center at the University of Miami, 1475 NW 12th Avenue, Miami, FL, 33136, USA.

Source: Blood cancer journal [Blood Cancer J] 2023 Jan 12; Vol. 13 (1), pp. 13. Date of Electronic Publication: 2023 Jan 12.

Publication Type: Letter

Journal Info: Publisher: Nature Pub. Group Country of Publication: United States NLM ID: 101568469 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-5385 (Electronic) Linking ISSN: 20445385 NLM ISO Abbreviation: Blood Cancer J Subsets: MEDLINE

MeSH Terms: Multiple Myeloma*/diagnosis, Humans ; Body Mass Index ; Bortezomib ; Treatment Outcome

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15

Academic Journal

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021.

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

16

Academic Journal

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

Authors: Chang E; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Pelosof L; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Lemery S; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Gong Y; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Goldberg KB; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Farrell AT; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Keegan P; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Veeraraghavan J; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Wei G; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Blumenthal GM; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Amiri-Kordestani L; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Singh H; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Fashoyin-Aje L; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Gormley N; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Kluetz PG; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Pazdur R; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Beaver JA; U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Theoret MR; U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Source: The oncologist [Oncologist] 2021 Oct; Vol. 26 (10), pp. e1786-e1799. Date of Electronic Publication: 2021 Jul 27.

Publication Type: Journal Article; Review

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

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17

Academic Journal

FDA approval summary: Crizotinib for pediatric and young adult patients with relapsed or refractory systemic anaplastic large cell lymphoma.

Authors: Merino M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Kasamon Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Li H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Ma L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Leong R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Zhou J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Reaman G; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Chambers W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Richardson N; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Theoret M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Gormley N; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Source: Pediatric blood & cancer [Pediatr Blood Cancer] 2022 Aug; Vol. 69 (8), pp. e29602. Date of Electronic Publication: 2022 May 13.

Publication Type: Journal Article

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

MeSH Terms: Immunoconjugates* , Lymphoma, Large-Cell, Anaplastic*/drug therapy , Lymphoma, Large-Cell, Anaplastic*/pathology, Child ; Crizotinib/therapeutic use ; Humans ; Neoplasm Recurrence, Local/drug therapy ; Protein Kinase Inhibitors/adverse effects ; United States ; United States Food and Drug Administration ; Young Adult

18

Academic Journal

Need for aligning the definition and reporting of cytokine release syndrome (CRS) in immuno-oncology clinical trials.

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

MeSH Terms: Cytokine Release Syndrome*/etiology , Immunotherapy*/adverse effects , Neoplasms*/therapy, Antibodies, Bispecific ; Clinical Trials as Topic ; Humans ; Immunotherapy, Adoptive/adverse effects

19

Academic Journal

Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies.

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

MeSH Terms: Antineoplastic Agents* , Hematologic Neoplasms*/complications , Hematologic Neoplasms*/drug therapy , Neoplasms*, Humans

20

Academic Journal

The saga of PI3K inhibitors in haematological malignancies: survival is the ultimate safety endpoint.

Authors: Richardson NC; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA. Electronic address: nicholas.richardson@fda.hhs.gov., Kasamon Y; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA., Pazdur R; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD 20993, USA., Gormley N; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA.

Source: The Lancet. Oncology [Lancet Oncol] 2022 May; Vol. 23 (5), pp. 563-566. Date of Electronic Publication: 2022 Apr 14.

Publication Type: Journal Article

Journal Info: Publisher: Lancet Pub. Group Country of Publication: England NLM ID: 100957246 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-5488 (Electronic) Linking ISSN: 14702045 NLM ISO Abbreviation: Lancet Oncol Subsets: MEDLINE

MeSH Terms: Hematologic Neoplasms*/drug therapy , Phosphatidylinositol 3-Kinases*, Humans ; Phosphoinositide-3 Kinase Inhibitors/adverse effects

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