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Rajeshwari Sridhara

Center for Drug Evaluation and Research

54

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Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis.

2021 Lancet Oncology
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FDA Approval Summary: Olaparib monotherapy or in combination with bevacizumab for the maintenance treatment of patients with advanced ovarian cancer.

2020 Oncologist
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US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017

2019 Lancet Oncology
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FDA Approval: Blinatumomab for patients with B-cell precursor acute lymphoblastic leukemia in morphologic remission with minimal residual disease

2019 Clinical Cancer Research
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An Empirical Investigation of Bayesian Clinical Trial Design in Metastatic Breast Cancer

2019 Therapeutic Innovation & Regulatory Science
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FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer

2018 Clinical Cancer Research
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Current Status and Future Perspectives on Neoadjuvant Therapy in Lung Cancer.

2018 Journal of Thoracic Oncology
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FDA Approval Summary: Pertuzumab for adjuvant treatment of HER2-positive early breast cancer

2018 Clinical Cancer Research
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Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis

2018 Lancet Oncology
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US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments.

2018 Journal of Clinical Oncology
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