Authors: Kim, G., McKee, A. E., Ning, Y.-M., Hazarika, M., Theoret, M., Johnson, J. R., Xu, Q. C., Tang, S., Sridhara, R., Jiang, X., He, K., Roscoe, D., McGuinn, W. D., Helms, W. S., Russell, A. M., Miksinski, S. P., Zirkelbach, J. F., Earp, J., Liu, Q., Ibrahim, A., Justice, R., Pazdur, R.
Subject Terms: Cancer Research, Oncology, QT interval, Vemurafenib, medicine.drug, medicine, Uveitis, medicine.disease, business.industry, business, Gastroenterology, medicine.medical_specialty, Toxic epidermal necrolysis, V600E, Rash, medicine.symptom, Surgery, Internal medicine, Dacarbazine, Nausea
Access URL: https://explore.openaire.eu/search/publication?articleId=doi_________::93089cb9aff87009dfa9d9e17fe66abb
Subject Terms: Article, Cancer Research, Oncology, Cancer, medicine.disease, medicine, business.industry, business, Cancer research, Adoptive cell transfer, Kinase insert domain receptor, Vascular endothelial growth factor A, Bevacizumab, medicine.drug, Melanoma, Immunology, Vascular endothelial growth factor, chemistry.chemical_compound, chemistry, Immunotherapy, medicine.medical_treatment
Access URL:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2239c9913175ee64754147ba1ad60d7a
https://europepmc.org/articles/PMC2912959/
Authors: Overwijk, W. W., Theoret, M. R., Nicholas P. Restifo
Source: Scopus-Elsevier
Subject Terms: Article
Access URL:
https://explore.openaire.eu/search/publication?articleId=pmid_dedup__::22ced2ea55063a7abefa5d4d1495c32e
http://www.scopus.com/inward/record.url?eid=2-s2.0-0033846635&partnerID=MN8TOARS
Authors: Bouchkouj N; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Lin X; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Wang X; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Przepiorka D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Xu Z; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Purohit-Sheth T; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Theoret M; 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 Oct 01; Vol. 27 (10), pp. 892-899.
Publication Type: Journal Article; Multicenter Study
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
Accede al texto completo Authors: Bouchkouj N; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Zimmerman M; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Kasamon YL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Wang C; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Dai T; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Xu Z; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Wang X; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Theoret M; 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., Purohit-Sheth T; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., George B; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Source: The oncologist [Oncologist] 2022 Jul 05; Vol. 27 (7), pp. 587-594.
Publication Type: Journal Article; Multicenter Study
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
Authors: Theoret M; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland., Shah M; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland., Rahman A; Division of Cancer Pharmacology II, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Source: Clinical advances in hematology & oncology : H&O [Clin Adv Hematol Oncol] 2022 Mar; Vol. 20 (3), pp. 148-150.
Publication Type: Interview
Journal Info: Publisher: Millennium Medical Pub Country of Publication: United States NLM ID: 101167661 Publication Model: Print Cited Medium: Internet ISSN: 1543-0790 (Print) Linking ISSN: 15430790 NLM ISO Abbreviation: Clin Adv Hematol Oncol Subsets: PubMed not MEDLINE; MEDLINE
Authors: Kasamon YL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Price LSL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Okusanya OO; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Richardson NC; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Li RJ; 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., Wu YT; 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 NJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Source: The oncologist [Oncologist] 2021 Oct; Vol. 26 (10), pp. 879-886. Date of Electronic Publication: 2021 Jul 01.
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
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
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
Authors: Pelosof L; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Saung MT; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Donoghue M; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Casak S; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Mushti S; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Cheng J; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Jiang X; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Liu J; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Zhao H; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Khazraee M; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Goldberg KB; Office of Oncologic Diseases, 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., Theoret M; Office of Oncologic Diseases, 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., Lemery S; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Pazdur R; Office of Oncologic Diseases, 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., Fashoyin-Aje L; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Source: The oncologist [Oncologist] 2021 Apr; Vol. 26 (4), pp. 318-324. Date of Electronic Publication: 2021 Jan 11.
Publication Type: Journal Article; Randomized Controlled Trial
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
Authors: Pinato DJ; Department of Surgery & Cancer, Imperial College London, Hammersmith Hospital, Du Cane Road, London, W120HS, UK. Electronic address: david.pinato@imperial.ac.uk., Marron TU; Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Mount Sinai Hospital, New York, NY, USA., Mishra-Kalyani PS; Office of Biostatistics, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA., Gong Y; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA., Wei G; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA., Szafron D; Dept of Internal Medicine, Baylor College of Medicine, Houston, TX, USA., Sharon E; Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA., Saeed A; Division of Medical Oncology, Department of Medicine, Kansas University Cancer Center, Westwood, KS, USA., Jun T; Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Mount Sinai Hospital, New York, NY, USA., Dharmapuri S; Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Mount Sinai Hospital, New York, NY, USA., Naqash AR; Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA., Peeraphatdit T; Section of Gastroenterology, Hepatology & Nutrition, The University of Chicago Medicine, 5841 S. Maryland Ave., Chicago, IL, 60637, USA., Gampa A; Section of Gastroenterology, Hepatology & Nutrition, The University of Chicago Medicine, 5841 S. Maryland Ave., Chicago, IL, 60637, USA., Wang Y; Department of Gastroenterology, Hepatology & Nutrition, The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Khan U; Division of Hematology and Oncology, Weill Cornell Medicine/New York Presbyterian Hospital, 1305 York Avenue, Room Y1247, New York, NY, 10021, USA., Muzaffar M; Division of Hematology/Oncology, East Carolina University, 600 Moye Boulevard, Greenville, NC, 27834, USA., Navaid M; Division of Hematology/Oncology, East Carolina University, 600 Moye Boulevard, Greenville, NC, 27834, USA., Lee CJ; Division of Gastroenterology and Hepatology, Taipei Veterans General Hospital, Taipei, Taiwan., Lee PC; Division of Gastroenterology and Hepatology, Taipei Veterans General Hospital, Taipei, Taiwan., Bulumulle A; Division of Hematology/Oncology, East Carolina University, 600 Moye Boulevard, Greenville, NC, 27834, USA., Yu B; Lincoln Medical Center, 234 East 149th Street, Bronx, NY, USA., Paul S; New York Presbyterian Brooklyn Methodist Hospital, 506 6th St, Brooklyn, NY, USA., Nimkar N; New York Presbyterian Brooklyn Methodist Hospital, 506 6th St, Brooklyn, NY, USA., Bettinger D; Department of Medicine II, Faculty of Medicine, Medical Center University of Freiburg, University of Freiburg, Freiburg, Germany., Hildebrand H; Division of Medical Oncology, Department of Medicine, Kansas University Cancer Center, Westwood, KS, USA., Abugabal YI; Dept of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Pressiani T; Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Milan, Pieve Emanuele, 20090, Italy., Personeni N; Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Milan, Pieve Emanuele, 20090, Italy., D'Alessio A; Department of Surgery & Cancer, Imperial College London, Hammersmith Hospital, Du Cane Road, London, W120HS, UK; Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Milan, Pieve Emanuele, 20090, Italy., Kaseb AO; Dept of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Huang YH; Division of Gastroenterology and Hepatology, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan., Ang C; Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Mount Sinai Hospital, New York, NY, USA., Schneider J; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA., Pillai A; Section of Gastroenterology, Hepatology & Nutrition, The University of Chicago Medicine, 5841 S. Maryland Ave., Chicago, IL, 60637, USA., Rimassa L; Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Milan, Pieve Emanuele, 20090, Italy; Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Via Manzoni 56, Milan, Rozzano, 20089, Italy., Goldberg KB; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA., Pazdur R; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA., Theoret M; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA., Lemery S; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA., Fashoyin-Aje '; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA., Cortellini A; Department of Surgery & Cancer, Imperial College London, Hammersmith Hospital, Du Cane Road, London, W120HS, UK; Department of Biotechnology and Applied Clinical Sciences, University of L'Aquila, Via Vetoio, L'Aquila, 67100, Italy. Electronic address: a.cortellini@imperial.ac.uk., Pelosof L; Office of Oncologic Diseases, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA. Electronic address: Lorraine.Pelosof@fda.hhs.gov.
Source: European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2021 Nov; Vol. 157, pp. 140-152. Date of Electronic Publication: 2021 Sep 08.
Publication Type: Journal Article; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 9005373 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0852 (Electronic) Linking ISSN: 09598049 NLM ISO Abbreviation: Eur J Cancer Subsets: MEDLINE
MeSH Terms: Carcinoma, Hepatocellular/*drug therapy , Immune Checkpoint Inhibitors/*adverse effects , Liver Neoplasms/*drug therapy, Adolescent ; Adult ; Aged ; Aged, 80 and over ; Carcinoma, Hepatocellular/mortality ; Clinical Trials as Topic ; Female ; Humans ; Liver Neoplasms/mortality ; Male ; Middle Aged ; Young Adult
Authors: Amiri-Kordestani L; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring. Electronic address: Laleh.AmiriKordestani@fda.hhs.gov., Xie D; Office of Biostatistics, Division of Biometrics V, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA., Tolaney SM; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA., Bloomquist E; Office of Biostatistics, Division of Biometrics V, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA., Tang S; Office of Biostatistics, Division of Biometrics V, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA., Ibrahim A; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring., Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA., Theoret MR; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA., Pazdur R; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA., Sridhara R; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, USA., Winer EP; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA., Beaver JA; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring.
Source: Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2020 Dec; Vol. 31 (12), pp. 1704-1708. Date of Electronic Publication: 2020 Aug 28.
Publication Type: Journal Article
Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 9007735 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1569-8041 (Electronic) Linking ISSN: 09237534 NLM ISO Abbreviation: Ann Oncol Subsets: MEDLINE
MeSH Terms: Breast Neoplasms*/drug therapy , Paclitaxel*/therapeutic use, Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Chemotherapy, Adjuvant ; Disease-Free Survival ; Humans ; Receptor, ErbB-2 ; Trastuzumab/therapeutic use ; United States ; United States Food and Drug Administration
Authors: Weinstock C; Chana Weinstock, MD; Laura L. Fernandes, PhD; Marc Theoret, MD; Shenghui Tang, PhD; Rajeshwari Sridhara, PhD; Julia A. Beaver, MD; and Richard Pazdur, MD, US Food and Drug Administration, Silver Spring, MD., Fernandes LL; Chana Weinstock, MD; Laura L. Fernandes, PhD; Marc Theoret, MD; Shenghui Tang, PhD; Rajeshwari Sridhara, PhD; Julia A. Beaver, MD; and Richard Pazdur, MD, US Food and Drug Administration, Silver Spring, MD., Theoret M; Chana Weinstock, MD; Laura L. Fernandes, PhD; Marc Theoret, MD; Shenghui Tang, PhD; Rajeshwari Sridhara, PhD; Julia A. Beaver, MD; and Richard Pazdur, MD, US Food and Drug Administration, Silver Spring, MD., Tang S; Chana Weinstock, MD; Laura L. Fernandes, PhD; Marc Theoret, MD; Shenghui Tang, PhD; Rajeshwari Sridhara, PhD; Julia A. Beaver, MD; and Richard Pazdur, MD, US Food and Drug Administration, Silver Spring, MD., Sridhara R; Chana Weinstock, MD; Laura L. Fernandes, PhD; Marc Theoret, MD; Shenghui Tang, PhD; Rajeshwari Sridhara, PhD; Julia A. Beaver, MD; and Richard Pazdur, MD, US Food and Drug Administration, Silver Spring, MD., Beaver JA; Chana Weinstock, MD; Laura L. Fernandes, PhD; Marc Theoret, MD; Shenghui Tang, PhD; Rajeshwari Sridhara, PhD; Julia A. Beaver, MD; and Richard Pazdur, MD, US Food and Drug Administration, Silver Spring, MD., Pazdur R; Chana Weinstock, MD; Laura L. Fernandes, PhD; Marc Theoret, MD; Shenghui Tang, PhD; Rajeshwari Sridhara, PhD; Julia A. Beaver, MD; and Richard Pazdur, MD, 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] 2020 Jan 01; Vol. 38 (1), pp. 106. Date of Electronic Publication: 2019 Nov 01.
Publication Type: Letter; Comment
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
MeSH Terms: Antibodies* , B7-H1 Antigen*, Humans
Authors: Howie LJ; US Food and Drug Administration, White Oak, MD., Singh H; US Food and Drug Administration, White Oak, MD., Bloomquist E; US Food and Drug Administration, White Oak, MD., Wedam S; US Food and Drug Administration, White Oak, MD., Amiri-Kordestani L; US Food and Drug Administration, White Oak, MD., Tang S; US Food and Drug Administration, White Oak, MD., Sridhara R; US Food and Drug Administration, White Oak, MD., Sanchez J; US Food and Drug Administration, White Oak, MD., Prowell TM; US Food and Drug Administration, White Oak, MD., Kluetz PG; US Food and Drug Administration, White Oak, MD., King-Kallimanis BL; US Food and Drug Administration, White Oak, MD., Gao JJ; US Food and Drug Administration, White Oak, MD., Ibrahim A; US Food and Drug Administration, White Oak, MD., Goldberg KB; US Food and Drug Administration, White Oak, MD., Theoret M; US Food and Drug Administration, White Oak, MD., Pazdur R; US Food and Drug Administration, White Oak, MD., Beaver JA; US Food and Drug Administration, White Oak, MD.
Source: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2019 Dec 20; Vol. 37 (36), pp. 3475-3483. Date of Electronic Publication: 2019 Sep 27.
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
MeSH Terms: Antineoplastic Combined Chemotherapy Protocols/*therapeutic use , Breast Neoplasms/*drug therapy, Aged ; Aged, 80 and over ; Aromatase Inhibitors/therapeutic use ; Breast Neoplasms/mortality ; Cyclin-Dependent Kinase 4/antagonists & inhibitors ; Cyclin-Dependent Kinase 6/antagonists & inhibitors ; Female ; Humans ; Middle Aged ; Progression-Free Survival ; Protein Kinase Inhibitors/therapeutic use ; Randomized Controlled Trials as Topic ; Receptors, Estrogen/biosynthesis ; Receptors, Progesterone/biosynthesis ; Treatment Outcome ; United States ; United States Food and Drug Administration
Authors: Maher VE; US Food and Drug Administration, Silver Spring, MD., Fernandes LL; US Food and Drug Administration, Silver Spring, MD., Weinstock C; US Food and Drug Administration, Silver Spring, MD., Tang S; US Food and Drug Administration, Silver Spring, MD., Agarwal S; US Food and Drug Administration, Silver Spring, MD., Brave M; US Food and Drug Administration, Silver Spring, MD., Ning YM; US Food and Drug Administration, Silver Spring, MD., Singh H; US Food and Drug Administration, Silver Spring, MD., Suzman D; US Food and Drug Administration, Silver Spring, MD., Xu J; US Food and Drug Administration, Silver Spring, MD., Goldberg KB; US Food and Drug Administration, Silver Spring, MD., Sridhara R; US Food and Drug Administration, Silver Spring, MD., Ibrahim A; US Food and Drug Administration, Silver Spring, MD., Theoret M; US Food and Drug Administration, Silver Spring, MD., Beaver JA; US Food and Drug Administration, Silver Spring, MD., Pazdur R; 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] 2019 Oct 20; Vol. 37 (30), pp. 2730-2737. Date of Electronic Publication: 2019 May 22.
Publication Type: Journal Article; Multicenter Study
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
MeSH Terms: Antibodies, Monoclonal/*adverse effects , Urologic Neoplasms/*complications, Adult ; Aged ; Aged, 80 and over ; Female ; Humans ; Male ; Middle Aged ; Survival Analysis ; Treatment Outcome ; Urologic Neoplasms/drug therapy ; Urologic Neoplasms/mortality
Authors: King-Kallimanis BL; Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: belinda.kallimanis@fda.hhs.gov., Kanapuru B; Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, MD, USA., Blumenthal GM; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Theoret MR; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA., Kluetz PG; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA.
Source: Seminars in oncology [Semin Oncol] 2018 Aug; Vol. 45 (4), pp. 201-209. Date of Electronic Publication: 2018 Oct 25.
Publication Type: Journal Article; Review
Journal Info: Publisher: W.B. Saunders Country of Publication: United States NLM ID: 0420432 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-8708 (Electronic) Linking ISSN: 00937754 NLM ISO Abbreviation: Semin Oncol Subsets: MEDLINE
MeSH Terms: Age Factors*, Antineoplastic Agents, Immunological/*adverse effects , Carcinoma, Non-Small-Cell Lung/*drug therapy , Lung Neoplasms/*drug therapy, Aged ; B7-H1 Antigen/antagonists & inhibitors ; Female ; Humans ; Immunotherapy/adverse effects ; Immunotherapy/methods ; Male ; Middle Aged ; Patient Reported Outcome Measures ; Programmed Cell Death 1 Receptor/antagonists & inhibitors ; Quality of Life ; Randomized Controlled Trials as Topic ; Surveys and Questionnaires ; Treatment Outcome
Authors: Kim G; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Geoffrey.Kim@fda.hhs.gov., McKee AE; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ning YM; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Hazarika M; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Theoret M; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Johnson JR; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Xu QC; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Sridhara R; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Jiang X; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., He K; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Roscoe D; Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiologic Health, U.S. Food and Drug Administration, Silver Spring, Maryland., McGuinn WD; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Helms WS; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Russell AM; Office of New Drug Quality Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Miksinski SP; Office of New Drug Quality Assessment, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zirkelbach JF; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Earp J; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Liu Q; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ibrahim A; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Justice R; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Office of Hematology and Oncology Products (OHOP), 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] 2014 Oct 01; Vol. 20 (19), pp. 4994-5000. Date of Electronic Publication: 2014 Aug 05.
Publication Type: Letter; 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
MeSH Terms: Drug Approval* , Indoles*/chemistry , Indoles*/pharmacology , Indoles*/therapeutic use , Sulfonamides*/chemistry , Sulfonamides*/pharmacology , Sulfonamides*/therapeutic use , United States Food and Drug Administration*, Animals ; Antineoplastic Agents/chemistry ; Antineoplastic Agents/pharmacology ; Antineoplastic Agents/therapeutic use ; Clinical Trials as Topic ; Drug Evaluation, Preclinical ; Humans ; Melanoma/drug therapy ; Melanoma/genetics ; Melanoma/mortality ; Melanoma/pathology ; Mutation ; Neoplasm Metastasis ; Proto-Oncogene Proteins B-raf/genetics ; Treatment Outcome ; United States ; Vemurafenib
Authors: Vatsan RS; Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), Rockville, MD, USA., Bross PF; Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), Rockville, MD, USA., Liu K; Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), Rockville, MD, USA., Theoret M; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Rockville, MD, USA., De Claro AR; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Rockville, MD, USA., Lu J; Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), Rockville, MD, USA., Helms W; Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Rockville, MD, USA., Niland B; Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), Rockville, MD, USA., Husain SR; Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), Rockville, MD, USA., Puri RK; Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), Rockville, MD, USA.
Source: Journal for immunotherapy of cancer [J Immunother Cancer] 2013 May 29; Vol. 1, pp. 5. Date of Electronic Publication: 2013 May 29 (Print Publication: 2013).
Publication Type: Journal Article; Review
Journal Info: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101620585 Publication Model: eCollection Cited Medium: Print ISSN: 2051-1426 (Print) Linking ISSN: 20511426 NLM ISO Abbreviation: J Immunother Cancer Subsets: PubMed not MEDLINE
Authors: Overwijk WW; Surgery Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892-1502, USA., Theoret MR, Restifo NP
Source: The cancer journal from Scientific American [Cancer J Sci Am] 2000 Feb; Vol. 6 Suppl 1, pp. S76-80.
Publication Type: Journal Article; Review
Journal Info: Publisher: Scientific American, Inc Country of Publication: United States NLM ID: 9513568 Publication Model: Print Cited Medium: Print ISSN: 1081-4442 (Print) Linking ISSN: 10814442 NLM ISO Abbreviation: Cancer J Sci Am Subsets: MEDLINE
MeSH Terms: Cancer Vaccines/*immunology , Interleukin-2/*therapeutic use , Neoplasms/*therapy, Animals ; CD8-Positive T-Lymphocytes/immunology ; Humans ; Immunotherapy, Adoptive ; Lymphocyte Activation ; Mice ; Neoplasms/immunology