Comparison of iRECIST versus RECIST V.1.1 in patients treated with an anti-PD-1 or PD-L1 antibody: pooled FDA analysis

por Mulkey, Flora, Theoret, Marc R, Keegan, Patricia, Pazdur, Richard, Sridhara, Rajeshwari
Publicado 2020

Development of Systemic and Topical Drugs to Treat Non-muscle Invasive Bladder Cancer

por Jarow, Jonathan, Maher, V. Ellen, Tang, Shenghui, Ibrahim, Amna, Kim, Geoffrey, Sridhara, Rajeshwari, Pazdur, Richard
Publicado 2015

FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti‐Angiogenic Therapy and Exploratory Predictive Biomarker Analysis

por Xu, James Xunhai, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Sridhara, Rajeshwari, Ibrahim, Amna, Kim, Geoffrey, Pazdur, Richard
Publicado 2017

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 Chem...

por 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
Publicado 2017

FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy

por 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
Publicado 2017

FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy

por 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.
Publicado 2018

An FDA Pooled Analysis of Patients with Melanoma Treated with an Anti-PD1 Antibody Beyond RECIST Progression

por Beaver, Julia A., Hazarika, Maitreyee, Mulkey, Flora, Mushti, Sirisha, Chen, Huanyu, He, Kun, Sridhara, Rajeshwari, Goldberg, Kirsten B., Chuk, Meredith K., Chi, Dow-Chung, Chang, Jennie, Barone, Amy, Balasubramaniam, Sanjeeve, Blumenthal, Gideon M., Keegan, Patricia, Pazdur, Richard, Theoret, Marc R.
Publicado 2018