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

par Jarow, Jonathan P., Lemery, Steven, Bugin, Kevin, Lowy, Naomi
Publié dans Ther Innov Regul Sci (2017)

Overview of FDA’s Expanded Access Program for Investigational Drugs

par Jarow, Jonathan P., Lurie, Peter, Ikenberry, Sarah Crowley, Lemery, Steven
Publié dans 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

par Jarow, Jonathan P., Lemery, Steven, Bugin, Kevin, Khozin, Sean, Moscicki, Richard
Publié dans 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

par Kazandjian, Dickran, Blumenthal, Gideon M., Luo, Lola, He, Kun, Fran, Ingrid, Lemery, Steven, Pazdur, Richard
Publié dans Oncologist (2016)

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

par Bradford, Diana, Demko, Suzanne, Jin, Susan, Mishra‐Kalyani, Pallavi, Beckles, Aaliyah R., Goldberg, Kirsten B., Lemery, Steven, Ward, Ashley, Keegan, Patricia, Pazdur, Richard
Publié dans 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

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

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

par 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.
Publié 2007

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

par 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
Publié 2011

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

par 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
Publié dans Oncologist (2018)

Benefit–Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine...

par Pelosof, Lorraine, Saung, May Tun, Donoghue, Martha, Casak, Sandra, Mushti, Sirisha, Cheng, Joyce, Jiang, Xiling, Liu, Jiang, Zhao, Hong, Khazraee, Maryam, Goldberg, Kirsten B., Theoret, Marc, Lemery, Steven, Pazdur, Richard, Fashoyin‐Aje, Lola
Publié dans Oncologist (2021)

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

par 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
Publié dans Clin Pharmacol Ther (2018)