Zobrazeno 1 - 10
of 18
pro vyhledávání: '"V. Ellen Maher"'
Autor:
Kirsten B. Goldberg, Richard Pazdur, Yang Min Ning, Gideon M. Blumenthal, Julia A. Beaver, V. Ellen Maher
Publikováno v:
The Oncologist
Within one year, five immunotherapies have been approved for the treatment of patients with locally advanced or metastatic urothelial cancer. The availability of these immunotherapies brings challenges to all stakeholders in the field. Additional res
Autor:
Yang-Min Ning, Shenghui Tang, V. Ellen Maher, Kirsten B. Goldberg, Tiffany K. Ricks, Richard Pazdur, Daniel L. Suzman, Wentao Fu, Lijun Zhang, Todd R. Palmby, Geoffrey Kim, Qi Liu
Publikováno v:
The Oncologist
On May 18, 2016, the U.S. Food and Drug Administration approved atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum‐containing chemotherapy or wit
Autor:
Lijun Zhang, Shenghui Tang, Richard Pazdur, V. Ellen Maher, James Xu, Rajeshwari Sridhara, Geoffrey Kim, Amna Ibrahim
Publikováno v:
The Oncologist
On November 23, 2015, the U.S. Food and Drug Administration approved nivolumab for patients with advanced renal cell carcinoma who have received prior anti‐angiogenic therapy. The overall benefit/risk profile demonstrated in trial CA209025 supporte
Autor:
Michael Brave, Rajeshwari Sridhara, Laura L. Fernandes, Julia A. Beaver, Chana Weinstock, Harpreet Singh, Shenghui Tang, Sundeep Agarwal, Amna Ibrahim, James Xu, Richard Pazdur, Daniel L. Suzman, Marc R. Theoret, Kirsten B. Goldberg, V. Ellen Maher, Yang Min Ning
Publikováno v:
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 37(30)
PURPOSE To assess the relationship among tumor response rate, overall survival, and the development of related adverse events of special interest (AESIs) or related immune-mediated adverse events (imAEs) in patients with urothelial cancer treated wit
Autor:
Shenghui Tang, Richard Pazdur, Amna Ibrahim, Rajeshwari Sridhara, Jonathan P. Jarow, V. Ellen Maher, Geoffrey Kim
Publikováno v:
Bladder Cancer
There are few approved drugs available for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) and none have been approved in the twenty-first century. Four drugs; thiotepa in 1959, BCG Tice in 1989, BCG Connaught in 1990, and v
Autor:
Amy E. McKee, Amna Ibrahim, Sundeep Agrawal, Laura L. Fernandes, Jason Schroeder, Shenghui Tang, V. Ellen Maher, Stella W. Karuri, Daniel L. Suzman, Yang Min Ning, Rajeshwari Sridhara, Richard Pazdur, Kirsten B. Goldberg, Julia A. Beaver
Publikováno v:
The Oncologist
This article summarizes the data supporting FDA approval of atezolizumab and pembrolizumab for the treatment of patients with advanced urothelial carcinoma ineligible for cisplatin‐based chemotherapy and the subsequent revision of the indications f
Autor:
Michael Brave, V. Ellen Maher, Amna Ibrahim, Richard Pazdur, Yang-Min Ning, Shenghui Tang, Lijun Zhang, Geoffrey Kim, Rajeshwari Sridhara
Publikováno v:
The Oncologist. 20:960-966
The U.S. Food and Drug Administration approved enzalutamide for the treatment of patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). At the prespecified interim analysis, a statistically significant improvement
Autor:
Yang-Min Ning, V. Ellen Maher
Publikováno v:
Urologic Oncology: Seminars and Original Investigations. 33:137-142
Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutic
Autor:
Yang-Min Ning, Nitin Mehrotra, Shenghui Tang, Debasis Ghosh, Lijun Zhang, Amna Ibrahim, Robeena Aziz, Amy Tilley, Richard Pazdur, Robert Justice, Elimika Pfuma, Paul G. Kluetz, Todd Palmby, Rajeshwari Sridhara, V. Ellen Maher, Jeanne Fourie Zirkelbach
Publikováno v:
Clinical Cancer Research. 19:6650-6656
On December 10, 2012, the U.S. Food and Drug Administration granted full approval for a modified indication for abiraterone acetate (Zytiga tablets; Janssen Biotech, Inc.) in combination with prednisone for the treatment of patients with metastatic c
Autor:
Wendy Wilson, Amna Ibrahim, Anthony J. Murgo, Brenda Gehrke, Suchitra Balakrishnan, Katherine Thornton, Shenghui Tang, Richard Pazdur, Anshu Marathe, Geoffrey Kim, Pengfei Song, Debasis Ghosh, Christine Garnett, Robert Justice, V. Ellen Maher, Brian Booth, John Duan, Young Jin Moon, Leigh Verbois, Qi Liu, Robert Dorsam, Lisa Skarupa, Somesh Chattopadhyay, Sarah Pope Miksinski, Hao Zhu, Haripada Sarker
Publikováno v:
Clinical Cancer Research. 18:3722-3730
On April 6, 2011, the U.S. Food and Drug Administration approved vandetanib (Caprelsa tablets; AstraZeneca Pharmaceuticals LP) for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable, locally advanced, o