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S. Lemery · SciRah

Researcher profile · Semantic Scholar

S. Lemery

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S. Lemery — researcher profile on SciRah

h-index: 30
Works: 86
Citations: 4,653

Most-cited papers

FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors
L. Marcus, S. Lemery, P. Keegan, R. Pazdur
2019Clinical Cancer Research991 citations Open access
Semantic Scholar
First FDA Approval Agnostic of Cancer Site - When a Biomarker Defines the Indication.
S. Lemery, P. Keegan, R. Pazdur
2017New England Journal of Medicine557 citations
Semantic Scholar
FDA Approval Summary: Pembrolizumab for the treatment of tumor mutational burden-high solid tumors
L. Marcus, L. Fashoyin-Aje, M. Donoghue, Mengdie Yuan +8 more
2021Clinical Cancer Research476 citations Open access
Semantic Scholar
Tumor necrosis factor alpha blockers and malignancy in children: forty-eight cases reported to the Food and Drug Administration.
Peter Diak, J. Siegel, L. L. La Grenade, Lauren Choi +2 more
2010Arthritis & Rheumatism238 citations
Semantic Scholar
FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma
S. Casak, M. Donoghue, L. Fashoyin-Aje, Xiao-Ping Jiang +13 more
2020Clinical Cancer Research149 citations
Semantic Scholar
FDA Approval Summary: Pembrolizumab for the first-line treatment of patients with MSI-H/dMMR advanced unresectable or metastatic colorectal carcinoma.
S. Casak, L. Marcus, L. Fashoyin-Aje, Sirisha L. Mushti +9 more
2021Clinical Cancer Research141 citations Open access
Semantic Scholar
Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.
P. Kluetz, Bindu Kanapuru, S. Lemery, L. Johnson +24 more
2017Value in Health111 citations Open access
Semantic Scholar
Relapse following discontinuation of imatinib mesylate therapy for FIP1L1/PDGFRA-positive chronic eosinophilic leukemia: implications for optimal dosing.
A. Klion, J. Robyn, I. Marić, W. Fu +9 more
2007Blood110 citations Open access
Semantic Scholar
U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab
S. Lemery, Jenny J. Zhang, Mark Rothmann, Jun Yang +8 more
2010Clinical Cancer Research99 citations
Semantic Scholar
FDA Approval Summary: Nivolumab plus ipilimumab for the treatment of patients with hepatocellular carcinoma previously treated with sorafenib.
M. T. Saung, L. Pelosof, S. Casak, M. Donoghue +10 more
2021The Oncologist89 citations Open access
Semantic Scholar
Systematic Review of PD‐1/PD‐L1 Inhibitors in Oncology: From Personalized Medicine to Public Health
Elaine Chang, L. Pelosof, S. Lemery, Yu-Tao Gong +14 more
2021The Oncologist83 citations Open access
Semantic Scholar
FDA Approval Summary: Ramucirumab for Gastric Cancer
S. Casak, Ibilola Fashoyin-Aje, S. Lemery, Lillian Zhang +14 more
2015Clinical Cancer Research80 citations Open access
Semantic Scholar
Benefit-Risk Summary of Crizotinib for the Treatment of Patients With ROS1 Alteration-Positive, Metastatic Non-Small Cell Lung Cancer
D. Kazandjian, G. Blumenthal, Lo-La Luo, Kun He +3 more
2016The Oncologist78 citations Open access
Semantic Scholar
Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021.
S. Agrawal, Shaily Arora, L. Amiri-Kordestani, R. A. de Claro +12 more
2022JAMA Oncology76 citations
Semantic Scholar
Multilineage involvement of the fusion gene in patients with FIP1L1/PDGFRA‐positive hypereosinophilic syndrome
J. Robyn, S. Lemery, J. McCoy, J. Kubofcik +5 more
2006British Journal of Haematology75 citations
Semantic Scholar
Overview of FDA’s Expanded Access Program for Investigational Drugs
J. Jarow, P. Lurie, Sarah Crowley Ikenberry, S. Lemery
2017Therapeutic Innovation and Regulatory Science71 citations Open access
Semantic Scholar
FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine–Refractory Differentiated Thyroid Cancer
Abhilasha Nair, S. Lemery, Jun Yang, Anshu Marathe +12 more
2015Clinical Cancer Research71 citations Open access
Semantic Scholar
Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period
J. Jarow, S. Lemery, K. Bugin, S. Khozin +1 more
2016Therapeutic Innovation and Regulatory Science70 citations Open access
Semantic Scholar
FDA Approval Summary: Ivosidenib for the treatment of patients with advanced unresectable or metastatic, chemotherapy refractory cholangiocarcinoma with an IDH1 mutation
S. Casak, S. Pradhan, L. Fashoyin-Aje, Yingying Ren +13 more
2022Clinical Cancer Research62 citations Open access
Semantic Scholar
FDA Approval Summary: Selpercatinib for the treatment of advanced RET fusion-positive solid tumors
Elizabeth S. Duke, Diana Bradford, M. Marcovitz, Anup K. Amatya +18 more
2023Clinical Cancer Research61 citations Open access
Semantic Scholar
Treatment-related toxicity and improved outcome from immunotherapy in hepatocellular cancer: Evidence from an FDA pooled analysis of landmark clinical trials with validation from routine practice.
D. Pinato, T. Marron, P. Mishra-Kalyani, Yu-Tao Gong +38 more
2021European Journal of Cancer58 citations
Semantic Scholar
Association between antibiotics and adverse oncological outcomes in patients receiving targeted or immune-based therapy for hepatocellular carcinoma
D. Pinato, Xiao-Xue Li, P. Mishra-Kalyani, A. D'Alessio +13 more
2023JHEP Reports56 citations Open access
Semantic Scholar
FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement
Timil H. Patel, L. Marcus, M. Horiba, M. Donoghue +13 more
2022Clinical Cancer Research51 citations Open access
Semantic Scholar
FDA Approval Summary: Tremelimumab in combination with durvalumab for the treatment of patients with unresectable hepatocellular carcinoma
Timil H Patel, Jamie R. Brewer, Jiaxin Fan, Joyce Cheng +7 more
2023Clinical Cancer Research50 citations Open access
Semantic Scholar
Neoadjuvant endocrine therapy in breast cancer.
C. Abrial, M. Mouret-Reynier, H. Curé, V. Feillel +6 more
2006Breast48 citations
Semantic Scholar
FDA Approval Summary: TAS-102
L. Marcus, S. Lemery, S. Khasar, E. Wearne +12 more
2017Clinical Cancer Research47 citations
Semantic Scholar
Eribulin Mesylate for the Treatment of Patients with Refractory Metastatic Breast Cancer: Use of a “Physician's Choice” Control Arm in a Randomized Approval Trial
M. Donoghue, S. Lemery, Weishi Yuan, Kun He +15 more
2012Clinical Cancer Research44 citations Open access
Semantic Scholar
Romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura.
Faranak Jamali, S. Lemery, Kassa Ayalew, Suzanne Robottom +3 more
2009Oncology43 citations
Semantic Scholar
U.S. Food and drug administration approval: rituximab in combination with fludarabine and cyclophosphamide for the treatment of patients with chronic lymphocytic leukemia.
S. Casak, S. Lemery, Yuan Shen, Mark Rothmann +6 more
2011The Oncologist37 citations Open access
Semantic Scholar
FDA Accelerated Approval of Pembrolizumab for Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma.
Diana Bradford, S. Demko, Susan Jin, P. Mishra-Kalyani +6 more
2020The Oncologist33 citations Open access
Semantic Scholar
Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety
J. Jarow, S. Lemery, K. Bugin, Naomi Lowy
2017Therapeutic Innovation and Regulatory Science28 citations Open access
Semantic Scholar
FDA Approval Summary: Tucatinib with trastuzumab for advanced unresectable or metastatic, chemotherapy refractory, HER2 positive RAS wild type colorectal cancer
S. Casak, M. Horiba, Mengdie Yuan, Joyce Cheng +11 more
2023Clinical Cancer Research27 citations Open access
Semantic Scholar
FDA's Approach to Regulating Biosimilars
S. Lemery, M. Ricci, P. Keegan, Amy E. McKee +1 more
2016Clinical Cancer Research27 citations Open access
Semantic Scholar
A pilot study evaluating the safety and CD34+ cell mobilizing activity of escalating doses of plerixafor in healthy volunteers
S. Lemery, Matthew M. Hsieh, Aleah L. Smith, Sheila Rao +10 more
2011British Journal of Haematology27 citations Open access
Semantic Scholar
FDA analysis of depth of response (DpR) and survival across 10 randomized controlled trials in patients with previously untreated unresectable or metastatic melanoma (UMM) by therapy type.
C. Osgood, Flora Mulkey, P. Mishra-Kalyani, S. Lemery +5 more
2019Journal of Clinical Oncology25 citations
Semantic Scholar
FDA's Approval of the First Biosimilar to Bevacizumab
S. Casak, S. Lemery, Jee Chung, C. Fuchs +10 more
2018Clinical Cancer Research25 citations Open access
Semantic Scholar
Tissue-Agnostic Drug Development.
K. Flaherty, D. Le, S. Lemery
2017American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting24 citations
Semantic Scholar
FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer
Michael J. Fusco, S. Casak, Sirisha L. Mushti, Joyce Cheng +17 more
2024Clinical Cancer Research23 citations Open access
Semantic Scholar
FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements
S. Gandhy, S. Casak, Sirisha L. Mushti, Joyce Cheng +16 more
2023Clinical Cancer Research22 citations Open access
Semantic Scholar
FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint inhibitors for the Treatment of Biliary Tract Cancer
S. Casak, Vaibhav Kumar, Chi Song, Mengdie Yuan +10 more
2024Clinical Cancer Research21 citations
Semantic Scholar
Subgroup analyses in oncology trials: regulatory considerations and case examples
Anup K. Amatya, M. Fiero, E. Bloomquist, A. Sinha +14 more
2021Clinical Cancer Research21 citations Open access
Semantic Scholar
Benefit‐Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib
L. Pelosof, S. Lemery, S. Casak, Xiao-Ping Jiang +10 more
2018The Oncologist21 citations Open access
Semantic Scholar
Tissue-Agnostic Drug Development: A New Path to Drug Approval.
K. Thein, S. Lemery, S. Kummar
2021Cancer Discovery19 citations Open access
Semantic Scholar
Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy
Sirisha L. Mushti, Flora Mulkey, Sheng-Hui Tang, H. Singh +8 more
2020Current Oncology Reports16 citations
Semantic Scholar
Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease
Robert N. Schuck, J. Woodcock, I. Zineh, P. Stein +14 more
2018Clinical pharmacology and therapy16 citations Open access
Semantic Scholar
Tissue-Agnostic Drug Development.
K. Flaherty, D. Le, S. Lemery
2017American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting15 citations
Semantic Scholar
Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study
Kun He, Huan-Yu Chen, T. Gwise, S. Casak +4 more
2016Clinical Cancer Research13 citations Open access
Semantic Scholar
Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
S. Lemery, R. Pazdur
2022Nature Reviews Clinical Oncology12 citations Open access
Semantic Scholar
Neoadjuvant Therapy for Melanoma: A U.S. Food and Drug Administration—Melanoma Research Alliance Public Workshop
Kristen L. Mueller, M. Theoret, S. Lemery, L. Amiri-Kordestani +20 more
2020Clinical Cancer Research12 citations Open access
Semantic Scholar
FDA Approval Summary: Ripretinib for advanced gastrointestinal stromal tumor (GIST)
Vaibhav Kumar, L. Doros, Margaret Thompson, Sirisha L. Mushti +9 more
2022Clinical Cancer Research10 citations Open access
Semantic Scholar

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