| 36790088 | The Association Between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients With Non-Small Cell Lung Cancer Treated With a PD-1/PD-L1 Blocking Antibody Using Real-World and Trial Data. | Clin Pharmacol Ther | 2023 |
| 34890212 | Response Rate, Event-Free Survival, and Overall Survival in Newly Diagnosed Acute Myeloid Leukemia: US Food and Drug Administration Trial-Level and Patient-Level Analyses. | J Clin Oncol | 2022 |
| 34196068 | Systematic Review of PD-1/PD-L1 Inhibitors in Oncology: From Personalized Medicine to Public Health. | Oncologist | 2021 |
| 34297598 | Model Development of CDK4/6 Predicted Efficacy in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer. | JCO Clin Cancer Inform | 2021 |
| 31444252 | FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults. | Clin Cancer Res | 2020 |
| 32001481 | FDA Approval Summary: Atezolizumab Plus Paclitaxel Protein-bound for the Treatment of Patients with Advanced or Metastatic TNBC Whose Tumors Express PD-L1. | Clin Cancer Res | 2020 |
| 31750870 | Eligibility and Radiologic Assessment for Adjuvant Clinical Trials in Kidney Cancer. | JAMA Oncol | 2020 |
| 31925955 | Application of Machine Learning in Drug Development and Regulation: Current Status and Future Potential. | Clin Pharmacol Ther | 2020 |
| 32047277 | Approvals in 2019: international review and a new agnostic molecular entity. | Nat Rev Clin Oncol | 2020 |
| 32017048 | Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases. | Clin Pharmacol Ther | 2020 |
| 31774473 | Application of the Lung Immune Prognostic Index From Research to Clinical Practice-Reply. | JAMA Oncol | 2020 |
| 31859246 | CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis. | Lancet Oncol | 2020 |
| 32043777 | FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease. | Oncologist | 2020 |
| 32091082 | Development, Validation, and Regulatory Considerations for a Liquid Biopsy Test. | Clin Chem | 2020 |
| 32865803 | Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer. | Ther Innov Regul Sci | 2020 |
| 32241586 | Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation. | Blood Rev | 2020 |
| 32518418 | Second cancers in adults with acute promyelocytic leukemia treated with or without arsenic trioxide: a SEER-medicare analysis. | Leukemia | 2020 |
| 32297444 | Evaluation of Serious Postmarket Safety Signals Within 2â¿¿Years of FDA Approval for New Cancer Drugs. | Oncologist | 2020 |
| 32201247 | Expanding Access to Lung Cancer Clinical Trials by Reducing the Use of Restrictive Exclusion Criteria: Perspectives of a Multistakeholder Working Group. | Clin Lung Cancer | 2020 |
| 32162806 | An Analysis of Recent FDA Oncology Scientific Publications. | Oncologist | 2020 |
| 31548341 | FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm. | Clin Cancer Res | 2020 |
| 29529128 | Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy. | Ann Oncol | 2019 |
| 31670753 | Eligibility and Radiologic Assessment in Adjuvant Clinical Trials in Bladder Cancer. | JAMA Oncol | 2019 |
| 32914013 | Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology, US Food and Drug Administration Public Workshop-Workshop Proceedings. | JCO Precis Oncol | 2019 |
| 31470129 | Radiologic Considerations and Standardization of Malignant Pleural Mesothelioma Imaging Within Clinical Trials: Consensus Statement from the NCI Thoracic Malignancy Steering Committee - International Association for the Study of Lung Cancer - Mesothelioma Applied Research Foundation Clinical Trials Planning Meeting. | J Thorac Oncol | 2019 |
| 31350329 | A Pilot Study of Sirolimus in Subjects with Cowden Syndrome or Other Syndromes Characterized by Germline Mutations in <i>PTEN</i>. | Oncologist | 2019 |
| 31343662 | Prognostic Value of the Lung Immune Prognostic Index for Patients Treated for Metastatic Non-Small Cell Lung Cancer. | JAMA Oncol | 2019 |
| 31513232 | Global Variation in Opioid Use in Prostate Cancer Trials. | JAMA Oncol | 2019 |
| 31367538 | A phase I/II study of pemetrexed with sirolimus in advanced, previously treated non-small cell lung cancer. | Transl Lung Cancer Res | 2019 |
| 30914464 | FDA Approval Summary: Brentuximab Vedotin in First-Line Treatment of Peripheral T-Cell Lymphoma. | Oncologist | 2019 |
| 30880446 | Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions. | Clin Trials | 2019 |
| 30723888 | Model-Informed Drug Development Approach to Expedite Approval: Case of Alectinib in First-Line Anaplastic Lymphoma Kinase + Non-Small Cell Lung Cancer. | Clin Pharmacol Ther | 2019 |
| 30817750 | Reproducibility of pharmacogenetics findings for paclitaxel in a heterogeneous population of patients with lung cancer. | PLoS One | 2019 |
| 30498095 | Clinical Development of Novel Drug-Radiotherapy Combinations. | Clin Cancer Res | 2019 |
| 30552112 | FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer. | Clin Cancer Res | 2019 |
| 30541745 | FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia. | Clin Cancer Res | 2019 |
| 30670830 | Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review. | Nat Rev Clin Oncol | 2019 |
| 30591549 | Real-World Outcomes of Patients with Metastatic Non-Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval. | Oncologist | 2019 |
| 30413526 | FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma. | Clin Cancer Res | 2019 |
| 30696689 | Challenges with Novel Clinical Trial Designs: Master Protocols. | Clin Cancer Res | 2019 |
| 28901535 | A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma. | Clin Pharmacol Ther | 2018 |
| 30268698 | Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer. | J Thorac Oncol | 2018 |
| 30266660 | 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. | J Thorac Oncol | 2018 |
| 30482633 | Age-related differences in patient-reported outcomes in patients with advanced lung cancer receiving anti-PD-1/PD-L1 therapy. | Semin Oncol | 2018 |
| 30391014 | FDA analyses of survival in older adults with metastatic non-small cell lung cancer in controlled trials of PD-1/PD-L1 blocking antibodies. | Semin Oncol | 2018 |
| 29361469 | Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis. | Lancet Oncol | 2018 |
| 29473145 | Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease. | Clin Pharmacol Ther | 2018 |
| 29523624 | U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer. | Clin Cancer Res | 2018 |
| 29494733 | A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review. | JAMA Oncol | 2018 |
| 29384145 | Approvals in 2017: gene therapies and site-agnostic indications. | Nat Rev Clin Oncol | 2018 |