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1

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

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

Journal:

Molecular Oncology

Year:

2015

Language:

english

File:

PDF, 471 KB

english, 2015

2

FDA analyses of survival in older adults with metastatic non–small cell lung cancer in controlled trials of PD-1/PD-L1 blocking antibodies

Marur, Shanthi, Singh, Harpreet, Mishra-Kalyani, Pallavi, Larkins, Erin, Keegan, Patricia, Sridhara, Rajeshwari, Blumenthal, Gideon M., Pazdur, Richard

Journal:

Seminars in Oncology

Year:

2018

Language:

english

File:

PDF, 849 KB

english, 2018

3

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

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, Am

Journal:

Year:

2018

Language:

english

File:

PDF, 205 KB

english, 2018

4

FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome

Kasamon, Yvette L., Chen, Haiyan, de Claro, R. Angelo, Nie, Lei, Ye, Jingjing, Blumenthal, Gideon M., Farrell, Ann T., Pazdur, Richard

Journal:

Clinical Cancer Research

Year:

2019

Language:

english

File:

PDF, 823 KB

english, 2019

5

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

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, Patri

Journal:

Year:

2017

Language:

english

File:

PDF, 365 KB

english, 2017

6

Current and Future Management of Malignant Mesothelioma: A Consensus Report from the National Cancer Institute Thoracic Malignancy Steering Committee, International Association for the Study of Lung Cancer, and Mesothelioma Applied Research Foundation

Tsao, Anne S., Lindwasser, O. Wolf, Adjei, Alex A., Adusumilli, Prasad S., Beyers, Matthew L., Blumenthal, Gideon M., Bueno, Raphael, Burt, Bryan M., Carbone, Michele, Dahlberg, Suzanne E., de Perrot,

Journal:

Journal of Thoracic Oncology

Year:

2018

Language:

english

File:

PDF, 407 KB

english, 2018

7

FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma

Bouchkouj, Najat, Kasamon, Yvette L., de Claro, R. Angelo, George, Bindu, Lin, Xue, Lee, Shiowjen, Blumenthal, Gideon M., Bryan, Wilson, McKee, Amy E., Pazdur, Richard

Journal:

Clinical Cancer Research

Year:

2018

Language:

english

File:

PDF, 1.29 MB

english, 2018

8

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

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

Journal:

Clinical Pharmacology & Therapeutics

Year:

2020

Language:

english

File:

PDF, 4.37 MB

english, 2020

9

Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer

Bonomi, Phil, Stuccio, Nina, Delgra, C. J., Chuk, Meredith K., Spira, Alexander, Deitz, Anne C., Blumenthal, Gideon M., Ferris, Andrea, Gong, Yutao, He, Jinghua, Basu Roy, Upal, Selig, Wendy

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2020

File:

PDF, 919 KB

2020

10

Differentiation therapy in poor risk myeloid malignancies: Results of a dose finding study of the combination bryostatin-1 and GM-CSF

B. Douglas Smith, Richard J. Jones, Eunpi Cho, Jeanne Kowalski, Judith E. Karp, Steven D. Gore, Milada Vala, Brooke Meade, Sharyn D. Baker, Ming Zhao, Steven Piantadosi, Zhe Zhang, Gideon Blumenthal,

Journal:

Leukemia Research

Year:

2011

Language:

english

File:

PDF, 396 KB

english, 2011

11

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

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

Journal:

Nature Reviews Cancer

Year:

2011

Language:

english

File:

PDF, 784 KB

english, 2011

12

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

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

Journal:

Nature Reviews Cancer

Year:

2011

File:

PDF, 40 KB

2011

13

Targeting the PI3K/Akt/mTOR pathway: Effective combinations and clinical considerations

Jaclyn LoPiccolo, Gideon M. Blumenthal, Wendy B. Bernstein, Phillip A. Dennis

Journal:

Drug Resistance Updates

Year:

2008

Language:

english

File:

PDF, 706 KB

english, 2008

14

PTEN hamartoma tumor syndromes

Blumenthal, Gideon M, Dennis, Phillip A

Journal:

European Journal of Human Genetics

Year:

2008

Language:

english

File:

PDF, 246 KB

english, 2008

15

Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy

Kazandjian, Dickran, Khozin, Sean, Blumenthal, Gideon, Zhang, Lijun, Tang, Shenghui, Libeg, Meredith, Kluetz, Paul, Sridhara, Rajeshwari, Keegan, Patricia, Pazdur, Richard

Journal:

Year:

2015

Language:

english

File:

PDF, 242 KB

english, 2015

16

Next-Generation Sequencing in Oncology in the Era of Precision Medicine

Blumenthal, Gideon M., Mansfield, Elizabeth, Pazdur, Richard

Journal:

Year:

2015

Language:

english

File:

PDF, 50 KB

english, 2015

17

Response Rate as an Approval End Point in Oncology

Blumenthal, Gideon M., Pazdur, Richard

Journal:

Year:

2016

Language:

english

File:

PDF, 106 KB

english, 2016

18

A Benefit Risk Analysis Approach To Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer

Raju, G. K., Gurumurthi, Karthik, Domike, Reuben, Kazandjian, Dickran, Blumenthal, Gideon, Pazdur, Richard, Woodcock, Janet

Journal:

Clinical Pharmacology & Therapeutics

Year:

2016

Language:

english

File:

PDF, 1.59 MB

english, 2016

19

Osimertinib for the Treatment of Metastatic EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer

Khozin, Sean, Weinstock, Chana, Blumenthal, Gideon M., Cheng, Joyce, He, Kun, Zhuang, Luning, Zhao, Hong, Charlab, Rosane, Fan, Ingrid, Keegan, Patricia, Pazdur, Richard

Journal:

Clinical Cancer Research

Year:

2016

Language:

english

File:

PDF, 231 KB

english, 2016

20

An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

Beaver, Julia A., Tzou, Abraham, Blumenthal, Gideon M., McKee, Amy E., Kim, Geoffrey, Pazdur, Richard, Philip, Reena

Journal:

Clinical Cancer Research

Year:

2017

Language:

english

File:

PDF, 234 KB

english, 2017

21

Characterization of outcomes in patients with metastatic non-small cell lung cancer treated with programmed cell death protein 1 inhibitors past RECIST version 1.1–defined disease progression in clinical trials

Kazandjian, Dickran, Keegan, Patricia, Suzman, Daniel L., Pazdur, Richard, Blumenthal, Gideon M.

Journal:

Seminars in Oncology

Year:

2017

Language:

english

File:

PDF, 762 KB

english, 2017

22

Approvals in 2016: the march of the checkpoint inhibitors

Blumenthal, Gideon M., Pazdur, Richard

Journal:

Nature Reviews Clinical Oncology (formerly Nature Clinical Practice Oncology)

Year:

2017

Language:

english

File:

PDF, 110 KB

english, 2017

23

U.S. Food and Drug Administration 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

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

Journal:

Year:

2017

Language:

english

File:

PDF, 187 KB

english, 2017

24

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

Li, Hongshan, Yu, Jingyu, Liu, Chao, Liu, Jiang, Subramaniam, Sriram, Zhao, Hong, Blumenthal, Gideon M., Turner, David C., Li, Claire, Ahamadi, Malidi, de Greef, Rik, Chatterjee, Manash, Kondic, Anna

Journal:

Journal of Pharmacokinetics and Pharmacodynamics

Year:

2017

Language:

english

File:

PDF, 1.55 MB

english, 2017

25

Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non–Small Cell Lung Cancer Trials

Blumenthal, Gideon M., Zhang, Lijun, Zhang, Hui, Kazandjian, Dickran, Khozin, Sean, Tang, Shenghui, Goldberg, Kirsten, Sridhara, Rajeshwari, Keegan, Patricia, Pazdur, Richard

Journal:

Year:

2017

Language:

english

File:

PDF, 501 KB

english, 2017

26

Treatment Beyond Progression With Immune Checkpoint Inhibitors—Known Unknowns

Blumenthal, Gideon M., Theoret, Marc R., Pazdur, Richard

Journal:

Year:

2017

Language:

english

File:

PDF, 123 KB

english, 2017

27

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

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

Journal:

Year:

2017

Language:

english

File:

PDF, 252 KB

english, 2017

28

Setting the Record Straight on FDA Approvals in Oncology

Blumenthal, Gideon, Kim, Geoffrey, Pazdur, Richard

Journal:

JAMA Internal Medicine

Year:

2017

Language:

english

File:

PDF, 66 KB

english, 2017

29

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

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

Journal:

Clinical Pharmacology & Therapeutics

Year:

2017

Language:

english

File:

PDF, 1.69 MB

english, 2017

30

Real-world Data for Clinical Evidence Generation in Oncology

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

Journal:

JNCI Journal of the National Cancer Institute

Year:

2017

Language:

english

File:

PDF, 627 KB

english, 2017

31

The FDA Oncology Center of Excellence and precision medicine

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

Journal:

Experimental Biology and Medicine

Year:

2017

Language:

english

File:

PDF, 92 KB

english, 2017

32

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

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, Donogh

Journal:

Year:

2017

Language:

english

File:

PDF, 260 KB

english, 2017

33

Approvals in 2017: gene therapies and site-agnostic indications

Blumenthal, Gideon M., Pazdur, Richard

Journal:

Nature Reviews Clinical Oncology (formerly Nature Clinical Practice Oncology)

Year:

2018

Language:

english

File:

PDF, 123 KB

english, 2018

34

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

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

Journal:

Clinical Pharmacology & Therapeutics

Year:

2018

Language:

english

File:

PDF, 965 KB

english, 2018

35

Leveraging the success of HIV drug development paradigms for cancer

Blumenthal, Gideon M., Birnkrant, Debra, Pazdur, Richard

Journal:

Clinical Cancer Research

Year:

2018

Language:

english

File:

PDF, 395 KB

english, 2018

36

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics

Beaver, Julia A., Howie, Lynn J., Pelosof, Lorraine, Kim, Tamy, Liu, Jinzhong, Goldberg, Kirsten B., Sridhara, Rajeshwari, Blumenthal, Gideon M., Farrell, Ann T., Keegan, Patricia, Pazdur, Richard, Kl

Journal:

Year:

2018

Language:

english

File:

PDF, 280 KB

english, 2018

37

Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma

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

Journal:

Year:

2018

Language:

english

File:

PDF, 152 KB

english, 2018

38

The First Year of the Food and Drug Administration Oncology Center of Excellence

Goldberg, Kirsten B., Blumenthal, Gideon M., Pazdur, Richard

Journal:

The Cancer Journal

Year:

2018

Language:

english

File:

PDF, 240 KB

english, 2018

39

Making Lung Cancer Clinical Trials More Inclusive: Recommendations for Expanding Eligibility Criteria

Bonomi, Philip, Blumenthal, Gideon, Ferris, Andrea Stern, Stewart, David J., Selig, Wendy K.D., Krug, Lee M., Allen, Jeff, Ison, Gwynn, Langer, Corey J., Melemed, Allen, Odogwu, Lauretta, Basu Roy, Up

Journal:

Journal of Thoracic Oncology

Year:

2018

Language:

english

File:

PDF, 164 KB

english, 2018

40

Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer

Blumenthal, Gideon M., Bunn, Paul A., Chaft, Jamie E., McCoach, Caroline E., Perez, Edith A., Scagliotti, Giorgio V., Carbone, David P., Aerts, Hugo J.W.L., Aisner, Dara L., Bergh, Jonas, Berry, Donal

Journal:

Journal of Thoracic Oncology

Year:

2018

File:

PDF, 1.04 MB

2018

41

Clinical Development of Novel Drug-Radiotherapy Combinations

Ahmad, Saif S, Crittenden, Marka R, Tran, Phuoc T., Kluetz, Paul G., Blumenthal, Gideon M., Bulbeck, Helen, Baird, Richard D, Williams, Kaye J, Illidge, Timothy, Hahn, Stephen, Lawrence, Theodore S.,

Journal:

Clinical Cancer Research

Year:

2018

Language:

english

File:

PDF, 934 KB

english, 2018

42

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

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

Journal:

Clinical Pharmacology & Therapeutics

Year:

2019

Language:

english

File:

PDF, 133 KB

english, 2019

43

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

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

Journal:

Year:

2019

Language:

english

File:

PDF, 830 KB

english, 2019

44

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

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

Journal:

Clinical Trials

Year:

2019

Language:

english

File:

PDF, 147 KB

english, 2019

45

A phase I/II study of pemetrexed with sirolimus in advanced, previously treated non-small cell lung cancer

Komiya, Takefumi, Memmott, Regan M., Blumenthal, Gideon M., Bernstein, Wendy, Ballas, Marc S., De Chowdhury, Roopa, Chun, Guinevere, Peer, Cody J., Figg, William D., Liewehr, David J., Steinberg, Seth

Journal:

Translational Lung Cancer Research

Year:

2019

Language:

english

File:

PDF, 1.00 MB

english, 2019

46

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

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.,

Journal:

Year:

2019

Language:

english

File:

PDF, 392 KB

english, 2019

47

A phase I/II study of pemetrexed with sirolimus in advanced, previously treated non-small cell lung cancer

Komiya, Takefumi, Memmott, Regan M., Blumenthal, Gideon M., Bernstein, Wendy, Ballas, Marc S., De Chowdhury, Roopa, Chun, Guinevere, Peer, Cody J., Figg, William D., Liewehr, David J., Steinberg, Seth

Journal:

Translational Lung Cancer Research

Year:

2019

File:

PDF, 1.00 MB

2019

48

Global Variation in Opioid Use in Prostate Cancer Trials

Roydhouse, Jessica K., Suzman, Daniel L., Menapace, Laurel A., Mishra-Kalyani, Pallavi S., Sridhara, Rajeshwari, Blumenthal, Gideon M., Beaver, Julia A., Pazdur, Richard, Kluetz, Paul G.

Journal:

Year:

2019

Language:

english

File:

PDF, 158 KB

english, 2019

49

Global Variation in Opioid Use in Prostate Cancer Trials

Roydhouse, Jessica K., Suzman, Daniel L., Menapace, Laurel A., Mishra-Kalyani, Pallavi S., Sridhara, Rajeshwari, Blumenthal, Gideon M., Beaver, Julia A., Pazdur, Richard, Kluetz, Paul G.

Journal:

Year:

2019

File:

PDF, 158 KB

2019

50

An Analysis of Recent FDA Oncology Scientific Publications

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

Journal:

Year:

2019

Language:

english

File:

PDF, 369 KB

english, 2019

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