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Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|October 10, 2020
Project Orbis: Global Collaborative Review ProgramR Angelo de Claro, Dianne Spillman, Lauren Tesh Hotaki, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|July 1, 2025
FDA Approval Summary: Ivosidenib for Treatment of Adult Patients with Relapsed/Refractory Myelodysplastic Syndrome with an IDH1 MutationAshley C Woods, E Dianne Pulte, Xin Wang, et al.Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology|December 10, 2021
Response Rate, Event-Free Survival, and Overall Survival in Newly Diagnosed Acute Myeloid Leukemia: US Food and Drug Administration Trial-Level and Patient-Level AnalysesKelly J Norsworthy, Xin Gao, Chia-Wen Ko, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|October 30, 2024
FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase 1 MutationAshley C Woods, Kelly J Norsworthy, Moran Choe, et al.JAMA Oncology|December 29, 2022
Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021Sundeep Agrawal, Shaily Arora, Laleh Amiri-Kordestani, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|August 1, 2024
FDA Approval Summary: Asciminib for Ph+ CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the T315I MutationGulsum E Pamuk, Edwin C Y Chow, Alexei C Ionan, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|January 26, 2026
FDA Approval Summary: Tarlatamab for the Treatment of Extensive Stage Small Cell Lung CancerYufan Liu, Jeannette Nashed, Amy K Barone, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|July 5, 2024
Perspectives on Drug Development for the Treatment of Chronic Myeloid Leukemia in Pregnant Patients and Patients Who Are BreastfeedingJorge E Cortes, Elisabetta Abruzzese, Elyce H Cardonick, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|February 26, 2021
FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-small Cell Lung Cancer, A Collaborative Project Orbis ReviewPaz J Vellanki, Flora Mulkey, Adnan A Jaigirdar, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|September 11, 2012
U.S. Food and Drug Administration approval summary: brentuximab vedotin for the treatment of relapsed Hodgkin lymphoma or relapsed systemic anaplastic large-cell lymphomaR Angelo de Claro, Karen McGinn, Virginia Kwitkowski, et al.Pageof 6