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Manuela Grimstein
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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: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer

Michael I. Barbato, Diana Bradford, Yi Ren, Stephanie L. Aungst, Claudia P. Miller, Lili Pan, Jeanne F. Zirkelbach, Yangbing Li, Youwei Bi, Jianghong Fan, Manuela Grimstein, Sarah E. Dorff, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Barbara Scepura, Peter Schotland, Opeyemi Udoka, Idara Ojofeitimi, John K. Leighton, Nam A. Rahman, Richard Pazdur, Harpreet Singh, Paul G. Kluetz, Nicole Drezner
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (16): 3364–3370.
https://doi.org/10.1158/1078-0432.CCR-24-0949
Published: 15 August 2024
View articletitled, FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer
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Journal Articles

FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Deepti Telaraja, Yvette L. Kasamon, Justin S. Collazo, Ruby Leong, Kun Wang, Ping Li, Elyes Dahmane, Yuching Yang, Justin Earp, Manuela Grimstein, Lisa R. Rodriguez, Marc R. Theoret, Nicole J. Gormley
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (1): 17–22.
https://doi.org/10.1158/1078-0432.CCR-23-1272
Published: 05 January 2024
View articletitled, FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
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Journal Articles

FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

Luckson N. Mathieu, Erin Larkins, Oladimeji Akinboro, Pourab Roy, Anup K. Amatya, Mallorie H. Fiero, Pallavi S. Mishra-Kalyani, Whitney S. Helms, Claire E. Myers, Amy M. Skinner, Stephanie Aungst, Runyan Jin, Hong Zhao, Huiming Xia, Jeanne Fourie Zirkelbach, Youwei Bi, Yangbing Li, Jiang Liu, Manuela Grimstein, Xinyuan Zhang, Stacie Woods, Kelie Reece, Abdelrahmman M. Abukhdeir, Soma Ghosh, Reena Philip, Shenghui Tang, Kirsten B. Goldberg, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2022) 28 (2): 249–254.
https://doi.org/10.1158/1078-0432.CCR-21-1566
Published: 19 January 2022
View articletitled, FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations
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