Works matching AU Blumenthal, Gideon

Results: 41

Optimizing public-private partnerships to support clinical cancer research.

Published in:

JNCI: Journal of the National Cancer Institute, 2025, v. 117, n. 7, p. 1305, doi. 10.1093/jnci/djae279

By:

Herbst, Roy S;
Blumenthal, Gideon;
Khleif, Samir N;
Lippman, Scott M;
Meropol, Neal J;
Rosati, Kristen;
Shulman, Lawrence N;
Smith, Heind;
Wang, Meina;
Winn, Robert A;
Schilsky, Richard L

Publication type:

Article

Clinical Trial Diversity in Oncology: FDA Takes Action with Post–Marketing Requirements or Commitments.

Published in:

Oncologist, 2022, v. 27, n. 12, p. 993, doi. 10.1093/oncolo/oyac228

By:

Kim, Janice;
Kester, Robert;
Blumenthal, Gideon

Publication type:

Article

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

Published in:

Oncologist, 2021, v. 26, n. 10, p. e1786, doi. 10.1002/onco.13887

By:

Chang, Elaine;
Pelosof, Lorraine;
Lemery, Steven;
Gong, Yutao;
Goldberg, Kirsten B.;
Farrell, Ann T.;
Keegan, Patricia;
Veeraraghavan, Janaki;
Wei, Guo;
Blumenthal, Gideon M.;
Amiri‐Kordestani, Laleh;
Singh, Harpreet;
Fashoyin‐Aje, Lola;
Gormley, Nicole;
Kluetz, Paul G.;
Pazdur, Richard;
Beaver, Julia A.;
Theoret, Marc R.

Publication type:

Article

Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs.

Published in:

Oncologist, 2020, v. 25, n. 4, p. 348, doi. 10.1634/theoncologist.2019-0653

By:

Kim, Janice;
Nair, Abhilasha;
Keegan, Patricia;
Beaver, Julia A.;
Kluetz, Paul G.;
Pazdur, Richard;
Chuk, Meredith;
Blumenthal, Gideon M.

Publication type:

Article

An Analysis of Recent FDA Oncology Scientific Publications.

Published in:

Oncologist, 2020, v. 25, n. 3, p. 266, doi. 10.1634/theoncologist.2019-0503

By:

Schneider, Julie A.;
Miklos, Andrew C.;
Onken, James;
Gong, Yutao;
Calcagno, Anna Maria;
Blumenthal, Gideon M.;
Aragon, Richard;
Pazdur, Richard

Publication type:

Article

FDA Approval Summary: Ruxolitinib for Treatment of Steroid‐Refractory Acute Graft‐Versus‐Host Disease.

Published in:

Oncologist, 2020, v. 25, n. 2, p. e328, doi. 10.1634/theoncologist.2019-0627

By:

Przepiorka, Donna;
Luo, Lola;
Subramaniam, Sriram;
Qiu, Junshan;
Gudi, Ramadevi;
Cunningham, Lea C.;
Nie, Lei;
Leong, Ruby;
Ma, Lian;
Sheth, Christopher;
Deisseroth, Albert;
Goldberg, Kirsten B.;
Blumenthal, Gideon M.;
Pazdur, Richard

Publication type:

Article

A Pilot Study of Sirolimus in Subjects with Cowden Syndrome or Other Syndromes Characterized by Germline Mutations in PTEN.

Published in:

Oncologist, 2019, v. 24, n. 12, p. 1510, doi. 10.1634/theoncologist.2019-0514

By:

Komiya, Takefumi;
Blumenthal, Gideon M.;
DeChowdhury, Roopa;
Fioravanti, Susan;
Ballas, Marc S.;
Morris, John;
Hornyak, Thomas J.;
Wank, Stephen;
Hewitt, Stephen M.;
Morrow, Betsy;
Memmott, Regan M.;
Rajan, Arun;
Dennis, Phillip A.

Publication type:

Article

FDA Approval Summary: Brentuximab Vedotin in First‐Line Treatment of Peripheral T‐Cell Lymphoma.

Published in:

Oncologist, 2019, v. 24, n. 5, p. e180, doi. 10.1634/theoncologist.2019-0098

By:

Richardson, Nicholas C.;
Kasamon, Yvette L.;
Chen, Haiyan;
de Claro, R. Angelo;
Ye, Jingjing;
Blumenthal, Gideon M.;
Farrell, Ann T.;
Pazdur, Richard

Publication type:

Article

Real‐World Outcomes of Patients with Metastatic Non‐Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval.

Published in:

Oncologist, 2019, v. 24, n. 5, p. 648, doi. 10.1634/theoncologist.2018-0307

By:

Khozin, Sean;
Carson, Kenneth R.;
Zhi, Jizu;
Tucker, Melisa;
Lee, Shannon E.;
Light, David E.;
Curtis, Melissa D.;
Bralic, Marta;
Kaganman, Irene;
Gossai, Anala;
Hofmeister, Philip;
Torres, Aracelis Z.;
Miksad, Rebecca A.;
Blumenthal, Gideon Michael;
Pazdur, Richard;
Abernethy, Amy P.

Publication type:

Article

FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations.

Published in:

Oncologist, 2018, v. 23, n. 6, p. 740, doi. 10.1634/theoncologist.2017-0642

By:

Odogwu, Lauretta;
Mathieu, Luckson;
Blumenthal, Gideon;
Larkins, Erin;
Goldberg, Kirsten B.;
Griffin, Norma;
Bijwaard, Karen;
Lee, Eunice Y.;
Philip, Reena;
Jiang, Xiaoping;
Rodriguez, Lisa;
McKee, Amy E.;
Keegan, Patricia;
Pazdur, Richard

Publication type:

Article

Characteristics of Real‐World Metastatic Non‐Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.

Published in:

Oncologist, 2018, v. 23, n. 3, p. 328, doi. 10.1634/theoncologist.2017-0353

By:

Khozin, Sean;
Abernethy, Amy P.;
Nussbaum, Nathan C.;
Zhi, Jizu;
Curtis, Melissa D.;
Tucker, Melisa;
Lee, Shannon E.;
Light, David E.;
Gossai, Anala;
Sorg, Rachael A.;
Torres, Aracelis Z.;
Patel, Payal;
Blumenthal, Gideon Michael;
Pazdur, Richard

Publication type:

Article

FDA Benefit‐Risk Assessment of Osimertinib for the Treatment of Metastatic Non‐Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation.

Published in:

Oncologist, 2018, v. 23, n. 3, p. 353, doi. 10.1634/theoncologist.2017-0425

By:

Odogwu, Lauretta;
Mathieu, Luckson;
Goldberg, Kirsten B.;
Blumenthal, Gideon M.;
Larkins, Erin;
Fiero, Mallorie H.;
Rodriguez, Lisa;
Bijwaard, Karen;
Lee, Eunice Y.;
Philip, Reena;
Fan, Ingrid;
Donoghue, Martha;
Keegan, Patricia;
McKee, Amy;
Pazdur, Richard

Publication type:

Article

Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma.

Published in:

2018

By:

Ning, Yang‐Min;
Maher, V. Ellen;
Beaver, Julia A.;
Goldberg, Kirsten B.;
Blumenthal, Gideon M.;
Pazdur, Richard

Publication type:

Editorial

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.

Published in:

Oncologist, 2017, v. 22, n. 11, p. 1392, doi. 10.1634/theoncologist.2017-0078

By:

Pai‐Scherf, Lee;
Blumenthal, Gideon M.;
Li, Hongshan;
Subramaniam, Sriram;
Mishra‐Kalyani, Pallavi S.;
He, Kun;
Zhao, Hong;
Yu, Jingyu;
Paciga, Mark;
Goldberg, Kirsten B.;
McKee, Amy E.;
Keegan, Patricia;
Pazdur, Richard

Publication type:

Article

FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy.

Published in:

Oncologist, 2017, v. 22, n. 7, p. 873, doi. 10.1634/theoncologist.2016-0496

By:

Larkins, Erin;
Blumenthal, Gideon M.;
Yuan, Weishi;
He, Kun;
Sridhara, Rajeshwari;
Subramaniam, Sriram;
Zhao, Hong;
Liu, Chao;
Yu, Jingyu;
Goldberg, Kirsten B.;
McKee, Amy E.;
Keegan, Patricia;
Pazdur, Richard

Publication type:

Article

Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies.

Published in:

Oncologist, 2017, v. 22, n. 7, p. 762, doi. 10.1634/theoncologist.2017-0152

By:

Blumenthal, Gideon M.;
Kluetz, Paul G.;
Schneider, Julie;
Goldberg, Kirsten B.;
McKee, Amy E.;
Pazdur, Richard

Publication type:

Article

Benefit-Risk Summary of Crizotinib for the Treatment of Patients With ROS1 Alteration-Positive, Metastatic Non-Small Cell Lung Cancer.

Published in:

Oncologist, 2016, v. 21, n. 8, p. 974, doi. 10.1634/theoncologist.2016-0101

By:

Kazandjian, Dickran;
Blumenthal, Gideon M.;
Luo, Lola;
He, Kun;
Fran, Ingrid;
Lemery, Steven;
Pazdur, Richard

Publication type:

Article

FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1.

Published in:

Oncologist, 2016, v. 21, n. 5, p. 643, doi. 10.1634/theoncologist.2015-0498

By:

Sul, Joohee;
Blumenthal, Gideon M.;
Jiang, Xiaoping;
He, Kun;
Keegan, Patricia;
Pazdur, Richard

Publication type:

Article

FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy.

Published in:

Oncologist, 2016, v. 21, n. 5, p. 634, doi. 10.1634/theoncologist.2015-0507

By:

Kazandjian, Dickran;
Suzman, Daniel L.;
Blumenthal, Gideon;
Mushti, Sirisha;
He, Kun;
Libeg, Meredith;
Keegan, Patricia;
Pazdur, Richard

Publication type:

Article

U.S. Food and Drug Administration Approval Summary: Ramucirumab for the Treatment of Metastatic Non-Small Cell Lung Cancer Following Disease Progression On or After Platinum-Based Chemotherapy.

Published in:

Oncologist, 2015, v. 20, n. 11, p. 1320, doi. 10.1634/theoncologist.2015-0221

By:

Larkins, Erin;
Scepura, Barbara;
Blumenthal, Gideon M.;
Bloomquist, Erik;
Tang, Shenghui;
Biable, Missiratch;
Kluetz, Paul;
Keegan, Patricia;
Pazdur, Richard

Publication type:

Article

Assessment of benefits and risks in development of targeted therapies for cancer – The view of regulatory authorities.

Published in:

Molecular Oncology, 2015, v. 9, n. 5, p. 1034, doi. 10.1016/j.molonc.2014.10.003

By:

Pignatti, Francesco;
Jonsson, Bertil;
Blumenthal, Gideon;
Justice, Robert

Publication type:

Article

The Association Between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients With Non‐Small Cell Lung Cancer Treated With a PD‐1/PD‐L1 Blocking Antibody Using Real‐World and Trial Data.

Published in:

Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 5, p. 1139, doi. 10.1002/cpt.2874

By:

Liu, Qi;
Mathur, Raina;
Xu, Yuan;
Torres, Aracelis Z.;
Miksad, Rebecca A.;
Liu, Chao;
Smithson, Haixia;
Wang, Yaning;
Zhu, Hao;
Booth, Brian;
Huang, Shiew‐Mei;
Zhi, Jizu;
Sridhara, Rajeshwari;
Blumenthal, Gideon Michael;
Larkins, Erin;
Mishra‐Kalyani, Pallavi S.;
Rivera, Donna R.;
Kluetz, Paul G.;
Sharon, Elad

Publication type:

Article

Application of Machine Learning in Drug Development and Regulation: Current Status and Future Potential.

Published in:

Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 4, p. 726, doi. 10.1002/cpt.1771

By:

Liu, Qi;
Zhu, Hao;
Liu, Chao;
Jean, Daphney;
Huang, Shiew‐Mei;
ElZarrad, M. Khair;
Blumenthal, Gideon;
Wang, Yaning

Publication type:

Article

Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases.

Published in:

Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 4, p. 730, doi. 10.1002/cpt.1747

By:

Febbo, Phillip G.;
Martin, Anne‐Marie;
Scher, Howard I.;
Barrett, J. Carl;
Beaver, Julia A.;
Beresford, Paul J.;
Blumenthal, Gideon M.;
Bramlett, Kelli;
Compton, Carolyn;
Dittamore, Ryan;
Eberhard, David A.;
Edelstein, Daniel;
Godsey, James;
Gruen, Andrew;
Hanlon, Sean E.;
Hicks, James;
Hovelson, Daniel;
Hullings, Melanie;
Johann, Donald;
Johnson, Justin

Publication type:

Article

FDA Approval Summary: Crizotinib for the Treatment of Metastatic Non-Small Cell Lung Cancer With Anaplastic Lymphoma Kinase Rearrangements.

Published in:

Oncologist, 2014, v. 19, n. 10, p. e5, doi. 10.1634/theoncologist.2014-0241

By:

Kazandjian, Dickran;
Blumenthal, Gideon M.;
Chen, Huan‐Yu;
He, Kun;
Patel, Mona;
Justice, Robert;
Keegan, Patricia;
Pazdur, Richard

Publication type:

Article

U.S.Food and Drug Administration Approval Summary:Erlotinib for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations.

Published in:

Oncologist, 2014, v. 19, n. 7, p. 774, doi. 10.1634/theoncologist.2014-0089

By:

Khozin, Sean;
Blumenthal, Gideon M.;
Jiang, Xiaoping;
He, Kun;
Boyd, Karen;
Murgo, Anthony;
Justice, Robert;
Keegan, Patricia;
Pazdur, Richard

Publication type:

Article

FDA Approval Summary: Sunitinib for the Treatment of Progressive Well-Differentiated Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors.

Published in:

Oncologist, 2012, v. 17, n. 8, p. 1108, doi. 10.1634/theoncologist.2012-0044

By:

Blumenthal, Gideon M.;
Cortazar, Patricia;
Zhang, Jenny J.;
Tang, Shenghui;
Sridhara, Rajeshwari;
Murgo, Anthony;
Justice, Robert;
Pazdur, Richard

Publication type:

Article

PTEN hamartoma tumor syndromes.

Published in:

European Journal of Human Genetics, 2008, v. 16, n. 11, p. 1289, doi. 10.1038/ejhg.2008.162

By:

Blumenthal, Gideon M.;
Dennis, Phillip A.

Publication type:

Article

Time dependent pharmacokinetics of pembrolizumab in patients with solid tumor and its correlation with best overall response.

Published in:

Journal of Pharmacokinetics & Pharmacodynamics, 2017, v. 44, n. 5, p. 403, doi. 10.1007/s10928-017-9528-y

By:

Li, Hongshan;
Yu, Jingyu;
Liu, Chao;
Liu, Jiang;
Subramaniam, Sriram;
Zhao, Hong;
Blumenthal, Gideon;
Turner, David;
Li, Claire;
Ahamadi, Malidi;
Greef, Rik;
Chatterjee, Manash;
Kondic, Anna;
Stone, Julie;
Booth, Brian;
Keegan, Patricia;
Rahman, Atiqur;
Wang, Yaning

Publication type:

Article

The FDA Oncology Center of Excellence and precision medicine.

Published in:

Experimental Biology & Medicine, 2018, v. 243, n. 3, p. 308, doi. 10.1177/1535370217740861

By:

Goldberg, Kirsten B.;
Blumenthal, Gideon M.;
McKee, Amy E.;
Pazdur, Richard

Publication type:

Article

PTEN loss in the continuum of common cancers, rare syndromes and mouse models.

Published in:

2011

By:

Hollander, M. Christine;
Blumenthal, Gideon M.;
Dennis, Phillip A.

Publication type:

Correction Notice

PTEN loss in the continuum of common cancers, rare syndromes and mouse models.

Published in:

2011

By:

Hollander, M. Christine;
Blumenthal, Gideon M.;
Dennis, Phillip A.

Publication type:

journal article

Expanding Access to Lung Cancer Clinical Trials by Reducing the Use of Restrictive Exclusion Criteria: Perspectives of a Multistakeholder Working Group.

Published in:

2020

By:

Forde, Patrick M.;
Bonomi, Phil;
Shaw, Alice;
Blumenthal, Gideon M.;
Ferris, Andrea;
Patel, Chirag;
Melemed, Allen;
Basu Roy, Upal;
Ramamoorthy, Anuradha;
Liu, Qi;
Burns, Timothy;
Gainor, Justin F.;
Lovly, Christine;
Piotrowska, Zofia;
Lehman, Jonathan;
Selig, Wendy

Publication type:

journal article

Reproducibility of pharmacogenetics findings for paclitaxel in a heterogeneous population of patients with lung cancer.

Published in:

PLoS ONE, 2019, v. 14, n. 2, p. 1, doi. 10.1371/journal.pone.0212097

By:

Sissung, Tristan M.;
Rajan, Arun;
Blumenthal, Gideon M.;
Liewehr, David J.;
Steinberg, Seth M.;
Berman, Arlene;
Giaccone, Giuseppe;
Figg, William D.

Publication type:

Article

Development, Validation, and Regulatory Considerations for a Liquid Biopsy Test.

Published in:

Clinical Chemistry, 2020, v. 66, n. 3, p. 408, doi. 10.1093/clinchem/hvaa010

By:

Tsui, Dana W. Y.;
Blumenthal, Gideon M.;
Philip, Reena;
Barrett, J. Carl;
Montagut, Clara;
Bramlett, Kelli;
Ladanyi, Marc;
Ghosh, Soma

Publication type:

Article

Model‐Informed Drug Development Approach to Expedite Approval: Case of Alectinib in First‐Line Anaplastic Lymphoma Kinase + Non‐Small Cell Lung Cancer.

Published in:

Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 4, p. 826, doi. 10.1002/cpt.1340

By:

Morcos, Peter N.;
Liu, Jiang;
Blumenthal, Gideon M.;
Zhao, Hong

Publication type:

Article

Considerations for Developing Targeted Therapies in Low‐Frequency Molecular Subsets of a Disease.

Published in:

Clinical Pharmacology & Therapeutics, 2018, v. 104, n. 2, p. 282, doi. 10.1002/cpt.1041

By:

Schuck, Robert N.;
Woodcock, Janet;
Zineh, Issam;
Stein, Peter;
Jarow, Jonathan;
Temple, Robert;
Permutt, Thomas;
LaVange, Lisa;
Beaver, Julia A.;
Charlab, Rosane;
Blumenthal, Gideon M.;
Dorff, Sarah E.;
Leptak, Christopher;
Lemery, Steven;
Rogers, Hobart;
Chowdhury, Badrul;
Litwack, E. David;
Pacanowski, Michael

Publication type:

Article

A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.

Published in:

Clinical Pharmacology & Therapeutics, 2018, v. 103, n. 1, p. 67, doi. 10.1002/cpt.871

By:

Raju, G. K.;
Gurumurthi, Karthik;
Domike, Reuben;
Kazandjian, Dickran;
Landgren, Ola;
Blumenthal, Gideon M.;
Farrell, Ann;
Pazdur, Richard;
Woodcock, Janet

Publication type:

Article

Real-world Data for Clinical Evidence Generation in Oncology.

Published in:

2017

By:

Khozin, Sean;
Blumenthal, Gideon M;
Pazdur, Richard

Publication type:

journal article

Setting the Record Straight on FDA Approvals in Oncology.

Published in:

2017

By:

Blumenthal, Gideon;
Kim, Geoffrey;
Pazdur, Richard

Publication type:

journal article

Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions.

Published in:

Clinical Trials, 2019, v. 16, n. 3, p. 322, doi. 10.1177/1740774519836991

By:

King-Kallimanis, Bellinda L;
Howie, Lynn J;
Roydhouse, Jessica K;
Singh, Harpreet;
Theoret, Marc R;
Blumenthal, Gideon M;
Kluetz, Paul G

Publication type:

Article