Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety

Por Jarow, Jonathan P., Lemery, Steven, Bugin, Kevin, Lowy, Naomi
Publicado no Ther Innov Regul Sci (2017)

Overview of FDA’s Expanded Access Program for Investigational Drugs

Por Jarow, Jonathan P., Lurie, Peter, Ikenberry, Sarah Crowley, Lemery, Steven
Publicado no Ther Innov Regul Sci (2017)

Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period

Por Jarow, Jonathan P., Lemery, Steven, Bugin, Kevin, Khozin, Sean, Moscicki, Richard
Publicado no Ther Innov Regul Sci (2016)

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 Accelerated Approval of Pembrolizumab for Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma

Por Bradford, Diana, Demko, Suzanne, Jin, Susan, Mishra‐Kalyani, Pallavi, Beckles, Aaliyah R., Goldberg, Kirsten B., Lemery, Steven, Ward, Ashley, Keegan, Patricia, Pazdur, Richard
Publicado no Oncologist (2020)

U.S. Food and Drug Administration Approval: Rituximab in Combination with Fludarabine and Cyclophosphamide for the Treatment of Patients with Chronic Lymphocytic Leukemia

Por Casak, Sandra J., Lemery, Steven J., Shen, Yuan Li, Rothmann, Mark D., Khandelwal, Aakanksha, Zhao, Hong, Davis, Gina, Jarral, Vaishali, Keegan, Patricia, Pazdur, Richard
Publicado em 2011

Relapse following discontinuation of imatinib mesylate therapy for FIP1L1/PDGFRA-positive chronic eosinophilic leukemia: implications for optimal dosing

Por Klion, Amy D., Robyn, Jamie, Maric, Irina, Fu, Weiming, Schmid, Laura, Lemery, Steven, Noel, Pierre, Law, Melissa A., Hartsell, Marilyn, Talar-Williams, Cheryl, Fay, Michael P., Dunbar, Cynthia E., Nutman, Thomas B.
Publicado em 2007

A pilot study evaluating the safety and CD34+ cell mobilizing activity of escalating doses of plerixafor in healthy volunteers

Por Lemery, Steven J., Hsieh, Matthew M., Smith, Aleah, Rao, Sheila, Khuu, Hanh M., Theresa, Donohue, Viano, Jennifer M., Cook, Lisa, Goodwin, Rose, Boss, Carol, Calandra, Gary, Geller, Nancy, Tisdale, John, Childs, Richard
Publicado em 2011

Benefit‐Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib

Por Pelosof, Lorraine, Lemery, Steven, Casak, Sandra, Jiang, Xiaoping, Rodriguez, Lisa, Pierre, Vadryn, Bi, Youwei, Liu, Jiang, Zirkelbach, Jeanne Fourie, Patel, Anuja, Goldberg, Kirsten B., McKee, Amy E., Keegan, Patricia, Pazdur, Richard
Publicado no Oncologist (2018)

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

Por 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, David, Pacanowski, Michael
Publicado no Clin Pharmacol Ther (2018)