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Journal Articles

FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase 1 Mutation

Ashley C. Woods, Kelly J. Norsworthy, Moran Choe, Brenda J. Gehrke, Haiyan Chen, Jonathon Vallejo, Lili Pan, Xiling Jiang, Hongshan Li, Jeffrey Kraft, Jiang Liu, Rosane Charlab, Olanrewaju O. Okusanya, Brian Booth, Richard Pazdur, Marc R. Theoret, R. Angelo de Claro
Journal: Clinical Cancer Research
Clin Cancer Res (2025) 31 (1): 12–17.
https://doi.org/10.1158/1078-0432.CCR-24-2196
Published: 06 January 2025
View article titled, FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an <em>Isocitrate Dehydrogenase 1</em> Mutation
Open the PDF for FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an <em>Isocitrate Dehydrogenase 1</em> Mutation in another window
Includes: Supplementary data
Journal Articles

FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation

Ashley Woods, Kelly J. Norsworthy, Xin Wang, Jonathon Vallejo, Edwin Chiu Yuen Chow, Ruo-Jing Li, Jielin Sun, Rosane Charlab, Xiling Jiang, Richard Pazdur, Marc R. Theoret, R. Angelo de Claro
Journal: Clinical Cancer Research
Clin Cancer Res (2024) 30 (7): 1226–1231.
https://doi.org/10.1158/1078-0432.CCR-23-2234
Published: 01 April 2024
View article titled, FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an <em>IDH1</em> Mutation
Open the PDF for FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an <em>IDH1</em> Mutation in another window
Includes: Supplementary data
Journal Articles

FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer

Jennifer J. Gao, Christy L. Osgood, Yutao Gong, Hui Zhang, Erik W. Bloomquist, Xiling Jiang, Junshan Qiu, Jingyu Yu, Pengfei Song, Nam Atiqur Rahman, Haw-Jyh Chiu, Tiffany K. Ricks, Fatima Rizvi, Sherry Hou, Willie Wilson, Abde M. Abukhdeir, Jeffrey Seidman, Soma Ghosh, Reena Philip, William F. Pierce, Vishal Bhatnagar, Paul G. Kluetz, Richard Pazdur, Julia A. Beaver, Laleh Amiri-Kordestani
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (8): 2126–2129.
https://doi.org/10.1158/1078-0432.CCR-20-3474
Published: 15 April 2021
View article titled, FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer
Open the PDF for FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer in another window
Journal Articles

FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer

Preeti Narayan, Tatiana M. Prowell, Jennifer J. Gao, Laura L. Fernandes, Emily Li, Xiling Jiang, Junshan Qiu, Jianghong Fan, Pengfei Song, Jingyu Yu, Xinyuan Zhang, Bellinda L. King-Kallimanis, Wei Chen, Tiffany K. Ricks, Yutao Gong, Xing Wang, Katherine Windsor, Steve Y. Rhieu, Gerlie Geiser, Anamitro Banerjee, Xiaohong Chen, Francisca Reyes Turcu, Deb K. Chatterjee, Anand Pathak, Jeffrey Seidman, Soma Ghosh, Reena Philip, Kirsten B. Goldberg, Paul G. Kluetz, Shenghui Tang, Laleh Amiri-Kordestani, Marc R. Theoret, Richard Pazdur, Julia A. Beaver
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1842–1849.
https://doi.org/10.1158/1078-0432.CCR-20-3652
Published: 01 April 2021
View article titled, FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer
Open the PDF for FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer in another window
Journal Articles

FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma

Sandra J. Casak, Martha Donoghue, Lola Fashoyin-Aje, Xiaoping Jiang, Lisa Rodriguez, Yuan-Li Shen, Yuan Xu, Xiling Jiang, Jiang Liu, Hong Zhao, William F. Pierce, Shubhangi Mehta, Kirsten B. Goldberg, Marc R. Theoret, Paul G. Kluetz, Richard Pazdur, Steven J. Lemery
Journal: Clinical Cancer Research
Clin Cancer Res (2021) 27 (7): 1836–1841.
https://doi.org/10.1158/1078-0432.CCR-20-3407
Published: 01 April 2021
View article titled, FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma
Open the PDF for FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma in another window