Search Results - "Ellen Maher, V."

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: Nivolumab in Advanced Renal Cell Carcinoma After Anti‐Angiogenic Therapy and Exploratory Predictive Biomarker Analysis by Xu, James Xunhai, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Sridhara, Rajeshwari, Ibrahim, Amna, Kim, Geoffrey, Pazdur, Richard

“…On November 23, 2015, the U.S. Food and Drug Administration approved nivolumab (OPDIVO, Bristol‐Myers Squibb Company) for patients with advanced renal cell…”
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Radium Ra 223 Dichloride Injection: U.S. Food and Drug Administration Drug Approval Summary by KLUETZ, Paul G, PIERCE, William, WEI CHEN, PALMBY, Todd, ALEBACHEW, Elleni, SRIDHARA, Rajeshwari, IBRAHIM, Amna, JUSTICE, Robert, PAZDUR, Richard, MAHER, V. Ellen, HUI ZHANG, SHENGHUI TANG, PENGFEI SONG, QI LIU, HABER, Martin T, LEUTZINGER, Eldon E, AL-HAKIM, Ali

“…On May 15, 2013, the U.S. Food and Drug Administration (FDA) approved radium Ra 223 dichloride (Ra-223; Xofigo injection; Bayer HealthCare Pharmaceuticals…”
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Immunization With Mutant p53- and K-ras–Derived Peptides in Cancer Patients: Immune Response and Clinical Outcome by CARBONE, David P, CIERNIK, I. Frank, PENDLETON, C. David, SEIFERT, Burkhardt, CARTER, Charley, READ, Elizabeth J, GREENBLATT, Jay, TOP, Lois E, KELSEY, Morris I, MINNA, John D, BERZOFSKY, Jay A, KELLEY, Michael J, SMITH, M. Charles, NADAF, Sorena, KAVANAUGH, Denise, MAHER, V. Ellen, STIPANOV, Michael, CONTOIS, David, JOHNSON, Bruce E

“…To determine the ability to induce tumor-specific immunity with individual mutant K-ras-or p53-derived peptides and to monitor clinical outcome. Patients in…”
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Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: Treatments in urologic oncology by Ning, Yang-Min, M.D., Ph.D, Maher, V. Ellen, M.D

“…Abstract Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of…”
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FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy by 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.

“…The U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab and pembrolizumab in April and May 2017, respectively, for the…”
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FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum‐Containing Chemotherapy by 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

“…Until recently in the United States, no products were approved for second‐line treatment of advanced urothelial carcinoma. On May 18, 2016, the U.S. Food and…”
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Vandetanib for the Treatment of Symptomatic or Progressive Medullary Thyroid Cancer in Patients with Unresectable Locally Advanced or Metastatic Disease: U.S. Food and Drug Administration Drug Approval Summary by THORNTON, Katherine, KIM, Geoffrey, GARNETT, Christine, QI LIU, BOOTH, Brian, GEHRKE, Brenda, DORSAM, Robert, VERBOIS, Leigh, GHOSH, Debasis, WILSON, Wendy, DUAN, John, SARKER, Haripada, MAHER, V. Ellen, POPE MIKSINSKI, Sarah, SKARUPA, Lisa, IBRAHIM, Amna, JUSTICE, Robert, MURGO, Anthony, PAZDUR, Richard, CHATTOPADHYAY, Somesh, SHENGHUI TANG, YOUNG JIN MOON, PENGFEI SONG, MARATHE, Anshu, BALAKRISHNAN, Suchitra, HAO ZHU

“…On April 6, 2011, the U.S. Food and Drug Administration approved vandetanib (Caprelsa tablets; AstraZeneca Pharmaceuticals LP) for the treatment of symptomatic…”
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U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy‐Naïve Metastatic Castration‐Resistant Prostate Cancer by Ning, Yang‐Min, Brave, Michael, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Sridhara, Rajeshwari, Kim, Geoffrey, Ibrahim, Amna, Pazdur, Richard

“…The U.S. Food and Drug Administration approved enzalutamide for the treatment of patients with chemotherapy‐naïve metastatic castration‐resistant prostate…”
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Abiraterone Acetate in Combination with Prednisone for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer: U.S. Food and Drug Administration Drug Approval Summary by KLUETZ, Paul G, NING, Yang-Min, MEHROTRA, Nitin, TILLEY, Amy, SRIDHARA, Rajeshwari, IBRAHIM, Amna, JUSTICE, Robert, PAZDUR, Richard, MAHER, V. Ellen, LIJUN ZHANG, SHENGHUI TANG, GHOSH, Debasis, AZIZ, Robeena, PALMBY, Todd, PFUMA, Elimika, ZIRKELBACH, Jeanne Fourie

“…On December 10, 2012, the U.S. Food and Drug Administration granted full approval for a modified indication for abiraterone acetate (Zytiga tablets; Janssen…”
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Enzalutamide for Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Previously Received Docetaxel: U.S. Food and Drug Administration Drug Approval Summary by NING, Yangmin M, PIERCE, William, QI LIU, GHOSH, Debasis, COTTRELL, Christy L, LEIGHTON, John, SRIDHARA, Rajeshwari, IBRAHIM, Amna, JUSTICE, Robert, PAZDUR, Richard, MAHER, V. Ellen, KARURI, Stella, TANG, Sheng-Hui, CHIU, Haw-Jyh, PALMBY, Todd, ZIRKELBACH, Jeanne Fourie, MARATHE, Dhananjay, MEHROTRA, Nitin

“…This article summarizes the regulatory evaluation that led to the full approval of enzalutamide (XTANDI, Medivation Inc.) by the U.S. Food and Drug…”
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Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma by Ning, Yang‐Min, Maher, V. Ellen, Beaver, Julia A., Goldberg, Kirsten B., Blumenthal, Gideon M., Pazdur, Richard

“…Within one year, five immunotherapies have been approved for the treatment of patients with locally advanced or metastatic urothelial cancer. The availability…”
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Oncogenic mutations in ras create HLA-A2.1 binding peptides but affect their extracellular antigen processing by Smith, M C, Pendleton, C D, Maher, V E, Kelley, M J, Carbone, D P, Berzofsky, J A

“…Point mutations in oncogene products such as ras may create neoantigenic determinants recognizable by T lymphocytes as tumor antigens, that could be marshalled…”
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Mice infected with Schistosoma mansoni develop a novel non-T-lymphocyte suppressor population which inhibits virus-specific CTL induction via a soluble factor by Marshall, Margaret A., Jankovic, Dragana, Ellen Maher, V., Sher, Alan, Berzofsky, Jay A.

“…We previously observed that Schistosoma mansoni-infected mice were deficient in their ability to mount a CTL response to unrelated viral antigens and to clear…”
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Simultaneous chronic lymphocytic leukemia and chronic myelogenous leukemia. Evidence of a separate stem cell origin by Maher, V E, Gill, L, Townes, P L, Wallace, J E, Savas, L, Woda, B A, Ansell, J E

“…The authors studied a patient with the simultaneous occurrence of chronic lymphocytic leukemia (CLL) and chronic myelogenous leukemia (CML). The coexistence of…”
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Mice infected with develop a novel non-T-lymphocyte suppressor population which inhibits virus-specific CTL induction via a soluble factor by Marshall, Margaret A., Jankovic, Dragana, Ellen Maher, V., Sher, Alan, Berzofsky, Jay A.

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Human antibody response to the intravenous and intraperitoneal administration of the F(ab')2 fragment of the OC125 murine monoclonal antibody by Maher, V E, Drukman, S J, Kinders, R J, Hunter, R E, Jennings, J, Brigham, C, Stevens, S, Griffin, T W

“…We have characterized the human immune response against murine monoclonal antibodies (HAMA) in 18 patients following administration of the F(ab')2 fragment of…”
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Combined antitumor therapy with the chemotherapeutic drug doxorubicin and an anti-transferrin receptor immunotoxin: in vitro and in vivo studies by Griffin, T W, Stocl, M, Collins, J, Fernandes, J, Maher, V E

“…We have determined the in vitro and in vivo efficacy of the combination of doxorubicin and an anti-transferrin receptor-monoclonal antibody (MAb)-ricin A chain…”
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