Search Results - "Richard Pazdur"

Endpoints for Assessing Drug Activity in Clinical Trials by Pazdur, Richard

“…Overall survival remains the gold standard for the demonstration of clinical benefit. An improvement in overall survival is a direct clinical benefit to…”
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First FDA Approval Agnostic of Cancer Site — When a Biomarker Defines the Indication by Lemery, Steven, Keegan, Patricia, Pazdur, Richard

“…In May 2017, the FDA approved pembrolizumab, a programmed death 1 inhibitor, for adult and pediatric patients with unresectable or metastatic,…”
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FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors by Marcus, Leigh, Lemery, Steven J, Keegan, Patricia, Pazdur, Richard

“…The FDA approved pembrolizumab on May 23, 2017, for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite…”
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Real-world Data for Clinical Evidence Generation in Oncology by Khozin, Sean, Blumenthal, Gideon M, Pazdur, Richard

“…Conventional cancer clinical trials can be slow and costly, often produce results with limited external validity, and are difficult for patients to participate…”
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Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015 by Jin, Susan, Pazdur, Richard, Sridhara, Rajeshwari

“…Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that…”
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The Wild West of Checkpoint Inhibitor Development by Beaver, Julia A, Pazdur, Richard

“…Although immunotherapy development has improved overall survival among patients with common cancers and has led to important therapeutic advances, rapid…”
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Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer by Prowell, Tatiana M, Pazdur, Richard

“…Neoadjuvant trials introduce new drugs preoperatively in patients with localized breast cancer, using the rate of pathological complete response as the primary…”
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Reevaluating Eligibility Criteria — Balancing Patient Protection and Participation in Oncology Trials by Beaver, Julia A, Ison, Gwynn, Pazdur, Richard

“…Specific patient populations are often excluded from oncology trials without clear reasons, which renders results less clearly applicable to all patients. A…”
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FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma by 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

“…In October 2017, the FDA granted regular approval to axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for treatment of…”
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FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC by Nakajima, Erica C, Drezner, Nicole, Li, Xiaoxue, Mishra-Kalyani, Pallavi S, Liu, Yajun, Zhao, Hong, Bi, Youwei, Liu, Jiang, Rahman, Atiqur, Wearne, Emily, Ojofeitimi, Idara, Hotaki, Lauren Tesh, Spillman, Dianne, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet

“…On May 28, 2021, the FDA granted accelerated approval to sotorasib (Lumakras, Amgen) for the treatment of adults with advanced non-small cell lung cancer…”
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FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1 by Fashoyin‐Aje, Lola, Donoghue, Martha, Chen, Huanyu, He, Kun, Veeraraghavan, Janaki, Goldberg, Kirsten B, Keegan, Patricia, McKee, Amy E, Pazdur, Richard

“…On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda, Merck & Co., Inc., Whitehouse…”
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Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody by Maher, V Ellen, Fernandes, Laura L, Weinstock, Chana, Tang, Shenghui, Agarwal, Sundeep, Brave, Michael, Ning, Yang-Min, Singh, Harpreet, Suzman, Daniel, Xu, James, Goldberg, Kirsten B, Sridhara, Rajeshwari, Ibrahim, Amna, Theoret, Marc, Beaver, Julia A, Pazdur, Richard

“…To assess the relationship among tumor response rate, overall survival, and the development of related adverse events of special interest (AESIs) or related…”
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FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden-High Solid Tumors by Marcus, Leigh, Fashoyin-Aje, Lola A, Donoghue, Martha, Yuan, Mengdie, Rodriguez, Lisa, Gallagher, Pamela S, Philip, Reena, Ghosh, Soma, Theoret, Marc R, Beaver, Julia A, Pazdur, Richard, Lemery, Steven J

“…The FDA approved pembrolizumab on June 16, 2020, for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high…”
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FDA Drug Approval Summary: Bevacizumab (Avastin®) as Treatment of Recurrent Glioblastoma Multiforme by Cohen, Martin H., Shen, Yuan Li, Keegan, Patricia, Pazdur, Richard

“…Learning Objectives After completing this course, the reader will be able to: Discuss and compare currently approved drugs for treatment of glioblastoma…”
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FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors by Marcus, Leigh, Donoghue, Martha, Aungst, Stephanie, Myers, Claire E, Helms, Whitney S, Shen, Guoxiang, Zhao, Hong, Stephens, Olen, Keegan, Patricia, Pazdur, Richard

“…The FDA-approved entrectinib on August 15, 2019, for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a…”
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Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms by Kluetz, Paul G, Slagle, Ashley, Papadopoulos, Elektra J, Johnson, Laura Lee, Donoghue, Martha, Kwitkowski, Virginia E, Chen, Wen-Hung, Sridhara, Rajeshwari, Farrell, Ann T, Keegan, Patricia, Kim, Geoffrey, Pazdur, Richard

“…Cancer clinical trials have relied on overall survival and measures of tumor growth or reduction to assess the efficacy of a drug. However, benefits are often…”
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FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis by Arora, Shaily, Balasubramaniam, Sanjeeve, Zhang, Wei, Zhang, Lijun, Sridhara, Rajeshwari, Spillman, Dianne, Mathai, Jaigi P, Scott, Bradley, Golding, Sarah J, Coory, Michael, Pazdur, Richard, Beaver, Julia A

“…On September 17, 2019, FDA granted accelerated approval to pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that…”
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FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond by 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

“…On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck & Co., Inc., https://www.merck.com) for treatment of…”
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FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non‐Small Cell Lung Cancers Harboring BRAF V600E Mutations by 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

“…On June 22, 2017, the Food and Drug Administration expanded indications for dabrafenib and trametinib to include treatment of patients with metastatic…”
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FDA Approval: Blinatumomab by Przepiorka, Donna, Ko, Chia-Wen, Deisseroth, Albert, Yancey, Carolyn L, Candau-Chacon, Reyes, Chiu, Haw-Jyh, Gehrke, Brenda J, Gomez-Broughton, Candace, Kane, Robert C, Kirshner, Susan, Mehrotra, Nitin, Ricks, Tiffany K, Schmiel, Deborah, Song, Pengfei, Zhao, Ping, Zhou, Qing, Farrell, Ann T, Pazdur, Richard

“…On December 3, 2014, the FDA granted accelerated approval of blinatumomab (Blincyto; Amgen, Inc.) for treatment of Philadelphia chromosome-negative relapsed or…”
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