Výsledky vyhledávání - "Sundeep Agrawal"

Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021

Autor: Sundeep Agrawal, Shaily Arora, Laleh Amiri-Kordestani, R. Angelo de Claro, Lola Fashoyin-Aje, Nicole Gormley, Tamy Kim, Steven Lemery, Gautam U. Mehta, Emma C. Scott, Harpreet Singh, Shenghui Tang, Marc R. Theoret, Richard Pazdur, Paul G. Kluetz, Julia A. Beaver

Publikováno v: JAMA oncology.

ImportanceSingle-arm trials have allowed for transformative therapies to be made available to patients expeditiously. However, using single-arm trials to support drug approval presents several challenges that must be carefully considered.Observations

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e83454b495d34188eddd7c73417f0cb
https://pubmed.ncbi.nlm.nih.gov/36580315

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FDA Approval Summary: lutetium Lu 177 vipivotide tetraxetan for patients with metastatic castration-resistant prostate cancer

Autor: Jaleh Fallah, Sundeep Agrawal, Haley Gittleman, Mallorie H. Fiero, Sriram Subramaniam, Christy John, Wei Chen, Tiffany K. Ricks, Gang Niu, Anthony Fotenos, Min Wang, Kelly Chiang, William F. Pierce, Daniel L. Suzman, Shenghui Tang, Richard Pazdur, Laleh Amiri-Kordestani, Amna Ibrahim, Paul G. Kluetz

Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research.

On March 23, 2022, the FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, also known as 177Lu-PSMA-617) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate ca

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1d1438960677231ad13675fee01eac7d
https://pubmed.ncbi.nlm.nih.gov/36469000

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FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs

Autor: Patricia Keegan, Jennifer J Gao, Martha Donoghue, Stacy Shifflett Shord, Abhilasha Nair, Richard Pazdur, Elleni Alebachew, William F. Pierce, Laurie B. Burke, R. Donald Harvey, George D. Demetri, Joohee Sul, Janice Kim, Harvey Katzen, Katherine Anne Thornton, Paul G. Kluetz, Sundeep Agrawal

Publikováno v: Clinical Cancer Research. 27:916-921

The FDA conducts independent reviews of scientific data obtained with investigational drug products to ensure that they are safe and effective. As a result of this process, FDA-approved product labeling is generated that is considered one of the most

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0d655328b16243898e9f4c59596829e5
https://doi.org/10.1158/1078-0432.ccr-20-3213

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Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies

Autor: Amna Ibrahim, Chana Weinstock, Sundeep Agrawal, Kirsten B. Goldberg, Julia A. Beaver, Shenghui Tang, Elaine Chang, Daniel L. Suzman, Jamie Renee Brewer, Richard Pazdur, Rajeshwari Sridhara, Harpreet Singh, Laura L. Fernandes, James Xu, Lijun Zhang, Joyce Cheng, Erik Bloomquist, Marc R. Theoret, Diqiong (Joan) Xie

Publikováno v: Clinical Cancer Research. 26:6406-6411

The development and review of combination drug regimens in oncology may present unique challenges to investigators and regulators. For regulatory approval of combination regimens, it is necessary to demonstrate the contribution of effect of each mono

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b54c8193b4f314849342452c5acd99f5
https://doi.org/10.1158/1078-0432.ccr-19-4229

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Clinical Evidence Generation During a Pandemic: Lessons Learned for Sustaining Progress

Autor: Donna R. Rivera, Paul G. Kluetz, Kald Abdallah, Sundeep Agrawal, Derek C. Angus, Robert M. Califf, Elizabeth Garrett-Mayer, Randall Hyer, Douglas R. Lowy, Samir N. Khleif

Publikováno v: Cancer journal (Sudbury, Mass.). 28(2)

Because of significant adaptations forced by the COVID-19 pandemic, resultant changes within health care delivery and clinical research introduced the potential for evaluation of novel evidence generation approaches in oncology. On July 26 and 27, 20

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7e89c30520229b435dd5576f34dba495
https://pubmed.ncbi.nlm.nih.gov/35333502

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Arterial aneurysm and dissection with systemic vascular endothelial growth factor inhibitors: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature

Autor: Michelle Nadeau Nguyen, Laleh Amiri-Kordestani, Daniel Woronow, Afrouz Nayernama, Michael Brave, S. Christopher Jones, Sundeep Agrawal, Connie Cheng

Publikováno v: Vascular medicine (London, England). 26(5)

The US Food and Drug Administration (FDA) has approved multiple systemic vascular endothelial growth factor (VEGF) inhibitors since 2004 to treat various malignancies. Inhibition of the VEGF signaling pathway can result in impairment of vascular wall

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::06c06fb4467fc2adcfb55bf5f0b29571
https://pubmed.ncbi.nlm.nih.gov/33840328

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