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

Por Pignatti, Francesco, Jonsson, Bertil, Blumenthal, Gideon, Justice, Robert
Publicado no Mol Oncol (2014)

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

Por LoPiccolo, Jaclyn, Blumenthal, Gideon M., Bernstein, Wendy B., Dennis, Phillip A.
Publicado em 2007

The FDA Oncology Center of Excellence and precision medicine

Por Goldberg, Kirsten B, Blumenthal, Gideon M, McKee, Amy E, Pazdur, Richard
Publicado no Exp Biol Med (Maywood) (2017)

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

Por Sul, Joohee, Blumenthal, Gideon M., Jiang, Xiaoping, He, Kun, Keegan, Patricia, Pazdur, Richard
Publicado no Oncologist (2016)

Management of Reproductive Health in Cowden Syndrome Complicated by Endometrial Polyps and Breast Cancer

Por Kalin, Asli, Merideth, Melissa A., Regier, Debra S., Blumenthal, Gideon M., Dennis, Phillip A., Stratton, Pamela
Publicado em 2013

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

Por Kazandjian, Dickran, Blumenthal, Gideon M., Luo, Lola, He, Kun, Fran, Ingrid, Lemery, Steven, Pazdur, Richard
Publicado no Oncologist (2016)

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

Por Kazandjian, Dickran, Suzman, Daniel L., Blumenthal, Gideon, Mushti, Sirisha, He, Kun, Libeg, Meredith, Keegan, Patricia, Pazdur, Richard
Publicado no Oncologist (2016)

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

Por Blumenthal, Gideon M., Kluetz, Paul G., Schneider, Julie, Goldberg, Kirsten B., McKee, Amy E., Pazdur, Richard
Publicado no Oncologist (2017)

Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma

Por Ning, Yang‐Min, Maher, V. Ellen, Beaver, Julia A., Goldberg, Kirsten B., Blumenthal, Gideon M., Pazdur, Richard
Publicado no Oncologist (2017)

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

Por Blumenthal, Gideon M., Cortazar, Patricia, Zhang, Jenny J., Tang, Shenghui, Sridhara, Rajeshwari, Murgo, Anthony, Justice, Robert, Pazdur, Richard
Publicado em 2012

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

Por Kazandjian, Dickran, Blumenthal, Gideon M., Chen, Huan-Yu, He, Kun, Patel, Mona, Justice, Robert, Keegan, Patricia, Pazdur, Richard
Publicado em 2014

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

Por Beaver, Julia A., Tzou, Abraham, Blumenthal, Gideon M., McKee, Amy E., Kim, Geoffrey, Pazdur, Richard, Philip, Reena
Publicado no Clin Cancer Res (2016)

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 De...

Por Khozin, Sean, Blumenthal, Gideon M., Jiang, Xiaoping, He, Kun, Boyd, Karen, Murgo, Anthony, Justice, Robert, Keegan, Patricia, Pazdur, Richard
Publicado em 2014

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...

Por Larkins, Erin, Scepura, Barbara, Blumenthal, Gideon M., Bloomquist, Erik, Tang, Shenghui, Biable, Missiratch, Kluetz, Paul, Keegan, Patricia, Pazdur, Richard
Publicado no Oncologist (2015)

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

Por Blumenthal, Gideon M., Zhang, Lijun, Zhang, Hui, Kazandjian, Dickran, Khozin, Sean, Tang, Shenghui, Goldberg, Kirsten, Sridhara, Rajeshwari, Keegan, Patricia, Pazdur, Richard
Publicado no JAMA Oncol (2017)

Overall Response Rate, Progression-Free Survival, and Overall Survival With Targeted and Standard Therapies in Advanced Non–Small-Cell Lung Cancer: US Food and Drug Administration...

Por Blumenthal, Gideon M., Karuri, Stella W., Zhang, Hui, Zhang, Lijun, Khozin, Sean, Kazandjian, Dickran, Tang, Shenghui, Sridhara, Rajeshwari, Keegan, Patricia, Pazdur, Richard
Publicado no J Clin Oncol (2015)

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 Chem...

Por 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
Publicado no Oncologist (2017)

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

Por 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
Publicado no Oncologist (2017)

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

Por 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
Publicado no Oncologist (2017)

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

Por 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
Publicado no Oncologist (2018)