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Journal Articles

FDA Approval Summary: Teclistamab–A Bispecific CD3 T-Cell Engager for Patients with Relapsed or Refractory Multiple Myeloma

Andrea C. Baines, Bindu Kanapuru, Jay Zhao, Lauren S.L. Price, Nan Zheng, Robyn Konicki, Michael L. Manning, Brenda J. Gehrke, Marc R. Theoret, Nicole J. Gormley
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (24): 5515–5520.
https://doi.org/10.1158/1078-0432.CCR-24-1872
Published: 16 December 2024
View articletitled, FDA Approval Summary: Teclistamab–A Bispecific CD3 T-Cell Engager for Patients with Relapsed or Refractory Multiple Myeloma
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Journal Articles

FDA Approval Summary: Asciminib for Ph+ CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the T315I Mutation

Gulsum E. Pamuk, Edwin C.Y. Chow, Alexei C. Ionan, Haiyan Chen, Shwu-Luan Lee, Vicky Hsu, Manuela Grimstein, Nan Zheng, Jielin Sun, Rosane Charlab, Brenda J. Gehrke, Jonathon Vallejo, Lori A. Ehrlich, R. Angelo de Claro, Marc R. Theoret
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (19): 4266–4271.
https://doi.org/10.1158/1078-0432.CCR-24-1086
Published: 01 October 2024
View articletitled, FDA Approval Summary: Asciminib for Ph+ CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the T315I Mutation
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Elizabeth S. Duke, Liza Stapleford, Nicole Drezner, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Yuan-Li Shen, Kimberly Maxfield, Jeanne Fourie Zirkelbach, Youwei Bi, Jiang Liu, Xinyuan Zhang, Hezhen Wang, Yuching Yang, Nan Zheng, Kelie Reece, Emily Wearne, Jacqueline J. Glen, Idara Ojofeitimi, Barbara Scepura, Abhilasha Nair, Rama Kamesh Bikkavilli, Soma Ghosh, Reena Philip, Richard Pazdur, Julia A. Beaver, Harpreet Singh, Martha Donoghue
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (3): 508–512.
https://doi.org/10.1158/1078-0432.CCR-22-2072
Published: 01 February 2023
View articletitled, FDA Approval Summary: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
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Journal Articles

U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer

Harpreet Singh, Amanda J. Walker, Laleh Amiri-Kordestani, Joyce Cheng, Shenghui Tang, Pamela Balcazar, Kimberly Barnett-Ringgold, Todd R. Palmby, Xianhua Cao, Nan Zheng, Qi Liu, Jingyu Yu, William F. Pierce, Selena R. Daniels, Rajeshwari Sridhara, Amna Ibrahim, Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2018) 24 (15): 3486–3491.
https://doi.org/10.1158/1078-0432.CCR-17-3628
Published: 31 July 2018
View articletitled, U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer
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