Search Results - "BROSS, Peter F"

Velcade®: U.S. FDA Approval for the Treatment of Multiple Myeloma Progressing on Prior Therapy by Kane, Robert C., Bross, Peter F., Farrell, Ann T., Pazdur, Richard

“…Learning Objectives After completing this course, the reader will be able to: Discuss the rationale and requirements for accelerated cancer drug approval by…”
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Approval summary for bortezomib for injection in the treatment of multiple myeloma by BROSS, Peter F, KANE, Robert, LEIGHTON, John, CHENG YI LIANG, LOSTRITTO, Richard T, MCGUINN, William D, MORSE, David E, RAHMAN, Atiqur, ROSARIO, Lilliam A, VERBOIS, S. Leigh, WILLIAMS, Grant, WANG, Yong-Cheng, FARRELL, Ann T, PAZDUR, Richard, ABRAHAM, Sophia, BENSON, Kimberly, BROWER, Margaret E, BRADLEY, Sean, GOBBURU, Jogarao V, GOHEER, Anwar, LEE, Shwu-Luan

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Regulation of biologic oncology products in the FDA׳s Center for Biologics Evaluation and Research by Bross, Peter F., M.D, Fan, Chaohong, M.D, George, Bindu, M.D, Shannon, Kevin, M.D, Joshi, Bharat H., Ph.D, Puri, Raj K., M.D., Ph.D

“…Abstract In the United States, cancer vaccines and immunotherapies, including cell and gene therapies and peptides and proteins used as therapeutic vaccines,…”
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Fulvestrant in Postmenopausal Women with Advanced Breast Cancer by BROSS, Peter F, BAIRD, Amy, WILLIAMS, Grant, PAZDUR, Richard, GANG CHEN, JEE, Josephine M, LOSTRITTO, Richard T, MORSE, David E, ROSARIO, Liliam A, WILLIAMS, Gene M, YANG, Peiling, RAHMAN, Atiqur

“…Purpose: Patients with hormone-sensitive breast cancer who have responded to tamoxifen (TAM) may receive additional benefit from a second endocrine agent after…”
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Approval summary: Gemtuzumab ozogamicin in relapsed acute myeloid leukemia by BROSS, Peter F, BEITZ, Julie, PAZDUR, Richard, GANG CHEN, XIAO HONG CHEN, DUFFY, Eric, KIEFFER, Lydia, ROY, Sandip, SRIDHARA, Rajeshwari, RAHMAN, Atiqur, WILLIAMS, Grant

“…Gemtuzumab ozogamicin (Mylotarg; Wyeth Laboratories, Philadelphia, PA) consists of a semisynthetic derivative of calicheamicin, a cytotoxic antibiotic linked…”
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Regulation of immunotherapeutic products for cancer and FDA's role in product development and clinical evaluation by Vatsan, Ramjay S, Bross, Peter F, Liu, Ke, Theoret, Marc, De Claro, Angelo R, Lu, Jinhua, Helms, Whitney, Niland, Brian, Husain, Syed R, Puri, Raj K

“…Immunotherapeutics include drugs and biologics that render therapeutic benefit by harnessing the power of the immune system. The promise of immune-mediated…”
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FDA Drug Approval Summaries: Fulvestrant by Bross, Peter F., Cohen, Martin H., Williams, Grant A., Pazdur, Richard

“…Patients with hormone‐sensitive breast cancer who have responded to tamoxifen may receive additional benefit from a second endocrine agent following…”
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Expanded access for cancer patients: The 5-year FDA CBER experience by Colbert, Laronna S., Bross, Peter F., Liu, Ke

“…Abstract only e18158 Background: Expanded access (EA) refers to the use of an investigational drug when the primary purpose is to diagnose, monitor, or treat a…”
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Approval Summary by Peter F. Bross, Julie Beitz, Gang Chen, Xiao Hong Chen, Eric Duffy, Lydia Kieffer, Sandip Roy, Rajeshwari Sridhara, Atiqur Rahman, Grant Williams, Richard Pazdur

“…Purpose : Gemtuzumab ozogamicin (Mylotarg; Wyeth Laboratories, Philadelphia, PA) consists of a semisynthetic derivative of calicheamicin, a cytotoxic…”
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