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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 article titled, 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: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults

Ruo-Jing Li, Runyan Jin, Chao Liu, Xianhua Cao, Michael L. Manning, Xu Michael Di, Donna Przepiorka, Frances Namuswe, Albert Deisseroth, Kirsten B. Goldberg, Gideon M. Blumenthal, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2020) 26 (2): 328–331.
https://doi.org/10.1158/1078-0432.CCR-19-1255
Published: 15 January 2020
View article titled, FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults
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Includes: Supplementary data
Journal Articles

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma

Meredith K. Chuk, Jennie T. Chang, Marc R. Theoret, Emmanuel Sampene, Kun He, Shawna L. Weis, Whitney S. Helms, Runyan Jin, Hongshan Li, Jingyu Yu, Hong Zhao, Liang Zhao, Mark Paciga, Deborah Schmiel, Rashmi Rawat, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2017) 23 (19): 5666–5670.
https://doi.org/10.1158/1078-0432.CCR-16-0663
Published: 01 October 2017
View article titled, FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma
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Journal Articles

FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs

Gwynn Ison, Julia A. Beaver, W. David McGuinn, Jr, Todd R. Palmby, Jeannette Dinin, Rosane Charlab, Anshu Marathe, Runyan Jin, Qi Liu, Xiao Hong Chen, Xavier Ysern, Olen Stephens, Ge Bai, Yaning Wang, Sarah E. Dorff, Joyce Cheng, Shenghui Tang, Rajeshwari Sridhara, William Pierce, Amy E. McKee, Amna Ibrahim, Geoffrey Kim, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2016) 22 (18): 4545–4549.
https://doi.org/10.1158/1078-0432.CCR-16-0638
Published: 15 September 2016
View article titled, FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs
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Journal Articles

FDA Approval Summary: Ramucirumab for Gastric Cancer

Sandra J. Casak, Ibilola Fashoyin-Aje, Steven J. Lemery, Lillian Zhang, Runyan Jin, Hongshan Li, Liang Zhao, Hong Zhao, Hui Zhang, Huanyu Chen, Kun He, Michele Dougherty, Rachel Novak, Sarah Kennett, Sachia Khasar, Whitney Helms, Patricia Keegan, Richard Pazdur
Journal: Clinical Cancer Research
Clin Cancer Res (2015) 21 (15): 3372–3376.
https://doi.org/10.1158/1078-0432.CCR-15-0600
Published: 02 August 2015
View article titled, FDA Approval Summary: Ramucirumab for Gastric Cancer
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