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Journal Articles

FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer

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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: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation–Positive Low-Grade Glioma

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Michael I. Barbato, Jeannette Nashed, Diana Bradford, Yi Ren, Sachia Khasar, Claudia P. Miller, Banu S. Zolnik, Hong Zhao, Yangbing Li, Youwei Bi, Stacy S. Shord, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Barbara Scepura, Raniya A. Al-Matari, Richard Pazdur, Paul G. Kluetz, Martha Donoghue, Harpreet Singh, Nicole Drezner
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (2): 263–268.
https://doi.org/10.1158/1078-0432.CCR-23-1503
Published: 17 January 2024
View articletitled, FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation–Positive Low-Grade Glioma
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Journal Articles

FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer

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Sandra J. Casak, M. Naomi Horiba, Mengdie Yuan, Joyce Cheng, Steven J. Lemery, Yuan Li Shen, Wentao Fu, Jason N. Moore, Yangbing Li, Youwei Bi, Doris Auth, Nataliya Fesenko, Paul G. Kluetz, Richard Pazdur, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (21): 4326–4330.
https://doi.org/10.1158/1078-0432.CCR-23-1041
Published: 01 November 2023
View articletitled, FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer
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Journal Articles

FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors

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Elizabeth S. Duke, Diana Bradford, Michelle Marcovitz, Anup K. Amatya, Pallavi S. Mishra-Kalyani, Emily Nguyen, Lauren S.L. Price, Jeanne Fourie Zirkelbach, Yangbing Li, Youwei Bi, Jeffrey Kraft, Sarah E. Dorff, Barbara Scepura, Maritsa Stephenson, Idara Ojofeitimi, Abhilasha Nair, Yu Han, Zivana Tezak, Steven J. Lemery, Richard Pazdur, Erin Larkins, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (18): 3573–3578.
https://doi.org/10.1158/1078-0432.CCR-23-0459
Published: 15 September 2023
View articletitled, FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors
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Journal Articles

FDA Approval Summary: Amivantamab for the Treatment of Patients with Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

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Katie Chon, Erin Larkins, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Stephanie Aungst, Emily Wearne, Sriram Subramaniam, Yangbing Li, Jiang Liu, Jielin Sun, Rosane Charlab, Hong Zhao, Banu Saritas-Yildirim, Rama Kamesh Bikkavilli, Soma Ghosh, Reena Philip, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (17): 3262–3266.
https://doi.org/10.1158/1078-0432.CCR-22-3713
Published: 01 September 2023
View articletitled, FDA Approval Summary: Amivantamab for the Treatment of Patients with Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement

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Timil H. Patel, Leigh Marcus, M. Naomi Horiba, Martha Donoghue, Somak Chatterjee, Pallavi S. Mishra-Kalyani, Robert N. Schuck, Yangbing Li, Xinyuan Zhang, Jeanne Fourie Zirkelbach, Rosane Charlab, Jiang Liu, Yuching Yang, Steven J. Lemery, Richard Pazdur, Marc R. Theoret, Lola A. Fashoyin-Aje
Journal: Clinical Cancer Research
Clin Cancer Res (2023) 29 (5): 838–842.
https://doi.org/10.1158/1078-0432.CCR-22-2036
Published: 01 March 2023
View articletitled, FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement
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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

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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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Journal Articles

FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review

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Abigail L. Koch, Paz J. Vellanki, Nicole Drezner, Xiaoxue Li, Pallavi S. Mishra-Kalyani, Yuan Li Shen, Huiming Xia, Yangbing Li, Jiang Liu, Jeanne Fourie Zirkelbach, Elitza Palazov, Aleksandr Gamarian, Qiuyi Choo, Arūnas Girčys, Ulrich-Peter Rohr, Nataliya Fesenko, Dianne Spillman, Richard Pazdur, Julia A. Beaver, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (24): 6638–6643.
https://doi.org/10.1158/1078-0432.CCR-21-1034
Published: 15 December 2021
View articletitled, FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review
Open the PDF for FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review in another window
Includes: Supplementary data
Journal Articles

FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

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Sonia Singh, Adnan A. Jaigirdar, Flora Mulkey, Joyce Cheng, Salaheldin S. Hamed, Yangbing Li, Jiang Liu, Hong Zhao, Anwar Goheer, Whitney S. Helms, Xing Wang, Rajiv Agarwal, Rajan Pragani, Kwadwo Korsah, Shenghui Tang, John Leighton, Atiqur Rahman, Julia A. Beaver, Richard Pazdur, Marc R. Theoret, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (9): 2378–2382.
https://doi.org/10.1158/1078-0432.CCR-20-3901
Published: 01 May 2021
View articletitled, FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions

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Diana Bradford, Erin Larkins, Sirisha L. Mushti, Lisa Rodriguez, Amy M. Skinner, Whitney S. Helms, Lauren S.L. Price, Jeanne Fourie Zirkelbach, Yangbing Li, Jiang Liu, Rosane Charlab, Francisca Reyes Turcu, Dun Liang, Soma Ghosh, Donna Roscoe, Reena Philip, Autumn Zack-Taylor, Shenghui Tang, Paul G. Kluetz, Julia A. Beaver, Richard Pazdur, Marc R. Theoret, Harpreet Singh
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (8): 2130–2135.
https://doi.org/10.1158/1078-0432.CCR-20-3558
Published: 15 April 2021
View articletitled, FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions
Open the PDF for FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions in another window
Includes: Supplementary data