Loading…
FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma
Bouchkouj, Najat, Kasamon, Yvette L., de Claro, R. Angelo, George, Bindu, Lin, Xue, Lee, Shiowjen, Blumenthal, Gideon M., Bryan, Wilson, McKee, Amy E., Pazdur, Richard
Published in Clinical cancer research (15.03.2019)
Published in Clinical cancer research (15.03.2019)
Get full text
Journal Article
Loading…
FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1
Fashoyin‐Aje, Lola, Donoghue, Martha, Chen, Huanyu, He, Kun, Veeraraghavan, Janaki, Goldberg, Kirsten B, Keegan, Patricia, McKee, Amy E, Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.01.2019)
Published in The oncologist (Dayton, Ohio) (01.01.2019)
Get full text
Journal Article
Loading…
FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations
Odogwu, Lauretta, Mathieu, Luckson, Blumenthal, Gideon, Larkins, Erin, Goldberg, Kirsten B., Griffin, Norma, Bijwaard, Karen, Lee, Eunice Y., Philip, Reena, Jiang, Xiaoping, Rodriguez, Lisa, McKee, Amy E., Keegan, Patricia, Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.06.2018)
Published in The oncologist (Dayton, Ohio) (01.06.2018)
Get full text
Journal Article
Loading…
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond
Pai‐Scherf, Lee, Blumenthal, Gideon M., Li, Hongshan, Subramaniam, Sriram, Mishra‐Kalyani, Pallavi S., He, Kun, Zhao, Hong, Yu, Jingyu, Paciga, Mark, Goldberg, Kirsten B., McKee, Amy E., Keegan, Patricia, Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.11.2017)
Published in The oncologist (Dayton, Ohio) (01.11.2017)
Get full text
Journal Article
Loading…
Loading…
FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy
Bhatnagar, Vishal, Gormley, Nicole J., Luo, Lola, Shen, Yuan Li, Sridhara, Rajeshwari, Subramaniam, Sriram, Shen, Guoxiang, Ma, Lian, Shord, Stacy, Goldberg, Kirsten B., Farrell, Ann T., McKee, Amy E., Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.11.2017)
Published in The oncologist (Dayton, Ohio) (01.11.2017)
Get full text
Journal Article
Loading…
FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
Pulte, Elizabeth Dianne, Dmytrijuk, Andrew, Nie, Lei, Goldberg, Kirsten B., McKee, Amy E., Farrell, Ann T., Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.06.2018)
Published in The oncologist (Dayton, Ohio) (01.06.2018)
Get full text
Journal Article
Loading…
The FDA Oncology Center of Excellence and precision medicine
Goldberg, Kirsten B, Blumenthal, Gideon M, McKee, Amy E, Pazdur, Richard
Published in Experimental biology and medicine (Maywood, N.J.) (01.02.2018)
Published in Experimental biology and medicine (Maywood, N.J.) (01.02.2018)
Get full text
Journal Article
Loading…
Loading…
An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies
Beaver, Julia A., Tzou, Abraham, Blumenthal, Gideon M., McKee, Amy E., Kim, Geoffrey, Pazdur, Richard, Philip, Reena
Published in Clinical cancer research (15.03.2017)
Published in Clinical cancer research (15.03.2017)
Get full text
Journal Article
Loading…
FDA's Approval of the First Biosimilar to Bevacizumab
Casak, Sandra J., Lemery, Steven J., Chung, Jee, Fuchs, Chana, Schrieber, Sarah J., Chow, Edwin C.Y., Yuan, Weishi, Rodriguez, Lisa, Gwise, Thomas, Rowzee, Anne, Lim, Sue, Keegan, Patricia, McKee, Amy E., Pazdur, Richard
Published in Clinical cancer research (15.09.2018)
Published in Clinical cancer research (15.09.2018)
Get full text
Journal Article
Loading…
The Role of the U.S. Food and Drug Administration Review Process: Clinical Trial Endpoints in Oncology
McKee, Amy E., Farrell, Ann T., Pazdur, Richard, Woodcock, Janet
Published in The oncologist (Dayton, Ohio) (01.01.2010)
Published in The oncologist (Dayton, Ohio) (01.01.2010)
Get full text
Journal Article
Loading…
Successes and Challenges of PARP Inhibitors in Cancer Therapy
Ricks, Tiffany K., Chiu, Haw-Jyh, Ison, Gwynn, Kim, Geoffrey, McKee, Amy E., Kluetz, Paul, Pazdur, Richard
Published in Frontiers in oncology (14.10.2015)
Published in Frontiers in oncology (14.10.2015)
Get full text
Journal Article
Loading…
Neuroblastoma Cells Isolated from Bone Marrow Metastases Contain a Naturally Enriched Tumor-Initiating Cell
Hansford, Loen M., McKee, Amy E., Zhang, Libo, George, Rani E., Gerstle, J. Ted, Thorner, Paul S., Smith, Kristen M., Look, A. Thomas, Yeger, Herman, Miller, Freda D., Irwin, Meredith S., Thiele, Carol J., Kaplan, David R.
Published in Cancer research (Chicago, Ill.) (01.12.2007)
Published in Cancer research (Chicago, Ill.) (01.12.2007)
Get full text
Journal Article
Loading…
Loading…
FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA -Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy
Kim, Geoffrey, Ison, Gwynn, McKee, Amy E., Zhang, Hui, Tang, Shenghui, Gwise, Thomas, Sridhara, Rajeshwari, Lee, Eunice, Tzou, Abraham, Philip, Reena, Chiu, Haw-Jyh, Ricks, Tiffany K., Palmby, Todd, Russell, Anne Marie, Ladouceur, Gaetan, Pfuma, Elimika, Li, Hongshan, Zhao, Liang, Liu, Qi, Venugopal, Rajesh, Ibrahim, Amna, Pazdur, Richard
Published in Clinical cancer research (01.10.2015)
Published in Clinical cancer research (01.10.2015)
Get full text
Journal Article
Loading…
FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum‐Containing Chemotherapy
Larkins, Erin, Blumenthal, Gideon M., Yuan, Weishi, He, Kun, Sridhara, Rajeshwari, Subramaniam, Sriram, Zhao, Hong, Liu, Chao, Yu, Jingyu, Goldberg, Kirsten B., McKee, Amy E., Keegan, Patricia, Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.07.2017)
Published in The oncologist (Dayton, Ohio) (01.07.2017)
Get full text
Journal Article
Loading…
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy
Suzman, Daniel L., Agrawal, Sundeep, Ning, Yang‐min, Maher, V. Ellen, Fernandes, Laura L., Karuri, Stella, Tang, Shenghui, Sridhara, Rajeshwari, Schroeder, Jason, Goldberg, Kirsten B., Ibrahim, Amna, McKee, Amy E., Pazdur, Richard, Beaver, Julia A.
Published in The oncologist (Dayton, Ohio) (01.04.2019)
Published in The oncologist (Dayton, Ohio) (01.04.2019)
Get full text
Journal Article
Loading…
Cancer drugs approved for use in children: Impact of legislative initiatives and future opportunities
Barone, Amy, Casey, Denise, McKee, Amy E., Reaman, Gregory
Published in Pediatric blood & cancer (01.08.2019)
Published in Pediatric blood & cancer (01.08.2019)
Get full text
Journal Article
Loading…
FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim‐Chester Disease with the BRAFV600 Mutation
Oneal, Patricia A., Kwitkowski, Virginia, Luo, Lola, Shen, Yuan Li, Subramaniam, Sriram, Shord, Stacy, Goldberg, Kirsten B., McKee, Amy E., Kaminskas, Edvardas, Farrell, Ann, Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.12.2018)
Published in The oncologist (Dayton, Ohio) (01.12.2018)
Get full text
Journal Article