Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies

por Blumenthal, Gideon M., Kluetz, Paul G., Schneider, Julie, Goldberg, Kirsten B., McKee, Amy E., Pazdur, Richard
Publicado 2017

Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma

por Ning, Yang‐Min, Maher, V. Ellen, Beaver, Julia A., Goldberg, Kirsten B., Blumenthal, Gideon M., Pazdur, Richard
Publicado 2017

FDA Approval Summary: Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

por Pulte, Elizabeth Dianne, Dmytrijuk, Andrew, Nie, Lei, Goldberg, Kirsten B., McKee, Amy E., Farrell, Ann T., Pazdur, Richard
Publicado 2018

FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B‐Cell Acute Lymphoblastic Leukemia

por Pulte, E. Dianne, Vallejo, Jonathon, Przepiorka, Donna, Nie, Lei, Farrell, Ann T., Goldberg, Kirsten B., McKee, Amy E., Pazdur, Richard
Publicado 2018

FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1

por Fashoyin‐Aje, Lola, Donoghue, Martha, Chen, Huanyu, He, Kun, Veeraraghavan, Janaki, Goldberg, Kirsten B., Keegan, Patricia, McKee, Amy E., Pazdur, Richard
Publicado 2018

FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum‐Containing Chemotherapy

por Ning, Yang‐Min, Suzman, Daniel, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Ricks, Tiffany, Palmby, Todd, Fu, Wentao, Liu, Qi, Goldberg, Kirsten B., Kim, Geoffrey, Pazdur, Richard
Publicado 2017

FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim‐Chester Disease with the BRAFV600 Mutation

por 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
Publicado 2018

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: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond

por 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
Publicado 2017

Benefit‐Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib

por Pelosof, Lorraine, Lemery, Steven, Casak, Sandra, Jiang, Xiaoping, Rodriguez, Lisa, Pierre, Vadryn, Bi, Youwei, Liu, Jiang, Zirkelbach, Jeanne Fourie, Patel, Anuja, Goldberg, Kirsten B., McKee, Amy E., Keegan, Patricia, Pazdur, Richard
Publicado 2018

FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations

por 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
Publicado 2018

FDA Benefit‐Risk Assessment of Osimertinib for the Treatment of Metastatic Non‐Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation

por Odogwu, Lauretta, Mathieu, Luckson, Goldberg, Kirsten B., Blumenthal, Gideon M., Larkins, Erin, Fiero, Mallorie H., Rodriguez, Lisa, Bijwaard, Karen, Lee, Eunice Y., Philip, Reena, Fan, Ingrid, Donoghue, Martha, Keegan, Patricia, McKee, Amy, 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

Systematic Review of PD‐1/PD‐L1 Inhibitors in Oncology: From Personalized Medicine to Public Health

por Chang, Elaine, Pelosof, Lorraine, Lemery, Steven, Gong, Yutao, Goldberg, Kirsten B., Farrell, Ann T., Keegan, Patricia, Veeraraghavan, Janaki, Wei, Guo, Blumenthal, Gideon M., Amiri‐Kordestani, Laleh, Singh, Harpreet, Fashoyin‐Aje, Lola, Gormley, Nicole, Kluetz, Paul G., Pazdur, Richard, Beaver, Julia A., Theoret, Marc R.
Publicado 2021