Search Results - "Suzman, Daniel L."

Castration-resistant prostate cancer: latest evidence and therapeutic implications by Suzman, Daniel L., Antonarakis, Emmanuel S.

“…Medical oncologists who treat men with castration-resistant prostate cancer (CRPC) have seen an abundance of new agents approved by the United States Food and…”
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Hepatotoxicity of immune checkpoint inhibitors: An evolving picture of risk associated with a vital class of immunotherapy agents by Suzman, Daniel L., Pelosof, Lorraine, Rosenberg, Amy, Avigan, Mark I.

“…Immune checkpoint inhibitors (ICIs) block CTLA‐4, PD‐1 and PD‐L1, or other molecules that control antitumour activities of lymphocytes. These products are…”
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FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non‐Small Cell Lung Cancer With Progression On or After Platinum‐Based Chemotherapy by Kazandjian, Dickran, Suzman, Daniel L., Blumenthal, Gideon, Mushti, Sirisha, He, Kun, Libeg, Meredith, Keegan, Patricia, Pazdur, Richard

“…On October 9, 2015, the U.S. Food and Drug Administration expanded the nivolumab metastatic non‐small cell lung cancer (NSCLC) indication to include patients…”
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FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer by Fallah, Jaleh, Agrawal, Sundeep, Gittleman, Haley, Fiero, Mallorie H, Subramaniam, Sriram, John, Christy, Chen, Wei, Ricks, Tiffany K, Niu, Gang, Fotenos, Anthony, Wang, Min, Chiang, Kelly, Pierce, William F, Suzman, Daniel L, Tang, Shenghui, Pazdur, Richard, Amiri-Kordestani, Laleh, Ibrahim, Amna, Kluetz, Paul G

“…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…”
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Characterization of outcomes in patients with metastatic non-small cell lung cancer treated with programmed cell death protein 1 inhibitors past RECIST version 1.1–defined disease progression in clinical trials by Kazandjian, Dickran, Keegan, Patricia, Suzman, Daniel L, Pazdur, Richard, Blumenthal, Gideon M

“…Abstract Based on anecdotal cases of clinically important decreases in tumor size following initial evidence of disease progression when treating patients with…”
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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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Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a US Food and Drug Administration pooled analysis by Fallah, Jaleh, Gittleman, Haley, Weinstock, Chana, Chang, Elaine, Agrawal, Sundeep, Tang, Shenghui, Pazdur, Richard, Kluetz, Paul G, Suzman, Daniel L, Amiri-Kordestani, Laleh

“…This pooled analysis of patient-level data from trials evaluated the clinical outcomes of patients with metastatic renal cell carcinoma with or without…”
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RE: is it time to reconsider the role of upfront cytoreductive nephrectomy in metastatic renal cell carcinoma? by Fallah, Jaleh, Gittleman, Haley, Weinstock, Chana, Chang, Elaine, Agrawal, Sundeep, Tang, Shenghui, Pazdur, Richard, Kluetz, Paul G, Suzman, Daniel L, Amiri-Kordestani, Laleh

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Clinical activity of enzalutamide versus docetaxel in men with castration-resistant prostate cancer progressing after abiraterone by Suzman, Daniel L., Luber, Brandon, Schweizer, Michael T., Nadal, Rosa, Antonarakis, Emmanuel S.

“…BACKGROUND The optimal sequencing of the multiple active agents now available for metastatic castration‐resistant prostate cancer (mCRPC) is unclear. Prior…”
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Efficacy of Poly(ADP-ribose) Polymerase Inhibitors by Individual Genes in Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer: A US Food and Drug Administration Pooled Analysis by Fallah, Jaleh, Xu, Jianjin, Weinstock, Chana, Gao, Xin, Heiss, Brian L, Maguire, William F, Chang, Elaine, Agrawal, Sundeep, Tang, Shenghui, Amiri-Kordestani, Laleh, Pazdur, Richard, Kluetz, Paul G, Suzman, Daniel L

“…We performed a pooled analysis of multiple trials of poly(ADP-ribose) polymerase inhibitors (PARPi) in metastatic castration-resistant prostate cancer (mCRPC)…”
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FDA Approval Summary: Belzutifan for VHL Disease Tumors-Response by Fallah, Jaleh, Weinstock, Chana, Mehta, Gautam U, Brave, Michael H, Pierce, William F, Pazdur, Richard, Nair, Abhilasha, Suzman, Daniel L, Amiri-Kordestani, Laleh

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FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma by Maguire, William F, Lee, Daniel, Weinstock, Chana, Gao, Xin, Bulik, Catharine C, Agrawal, Sundeep, Chang, Elaine, Hamed, Salaheldin S, Bloomquist, Erik W, Tang, Shenghui, Pazdur, Richard, Kluetz, Paul G, Amiri-Kordestani, Laleh, Suzman, Daniel L

“…On April 3, 2023, the FDA granted accelerated approval to enfortumab vedotin-ejfv (EV) plus pembrolizumab for treatment of patients with locally advanced or…”
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Equipoise Lost? Trial Conduct Challenges in an Era of Breakthrough Therapies by Fallah, Jaleh, Mulkey, Flora, Fiero, Mallorie H, Gittleman, Haley, Song, Chi, Puthiamadathil, Jeevan, Amatya, Anup, Agrawal, Sundeep, Vellanki, Paz, Suzman, Daniel L, Singh, Harpreet, Amiri-Kordestani, Laleh, Mishra-Kalyani, Pallavi, Pazdur, Richard, Kluetz, Paul G

“…FDA Oncology Center's @Falleh_Fallah and colleagues discuss loss of equipoise and other trial conduct challenges in an era of breakthrough therapies - via…”
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FDA Approval Summary: Belzutifan for Patients with Advanced Renal Cell Carcinoma by Fallah, Jaleh, Heiss, Brian L, Joeng, Hee-Koung, Weinstock, Chana, Gao, Xin, Pierce, William F, Chukwurah, Benjamin, Bhatnagar, Vishal, Fiero, Mallorie H, Amiri-Kordestani, Laleh, Pazdur, Richard, Kluetz, Paul G, Suzman, Daniel L

“…On December 14, 2023, the United States Food and Drug Administration (FDA) approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal…”
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FDA Approval Summary: Enfortumab Vedotin Plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma by Brave, Michael H, Maguire, William F, Weinstock, Chana, Zhang, Hui, Gao, Xin, Li, Fang, Yu, Jingyu, Fu, Wentao, Zhao, Hong, Pierce, William F, Chang, Elaine, Dinin, Jeannette, Fiero, Mallorie H, Rahman, Nam Atiqur, Tang, Shenghui, Pazdur, Richard, Kluetz, Paul G, Amiri-Kordestani, Laleh, Suzman, Daniel L

“…On December 15, 2023, the FDA granted traditional approval to enfortumab vedotin-ejfv plus pembrolizumab (EV + Pembro) for patients with locally advanced or…”
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A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma by Chang, Elaine, Zhou, Jiaxi, Song, Chi, Gittleman, Haley, Fernandes, Laura, Weinstock, Chana, Atkins, Michael B, Agrawal, Sundeep, Sridhara, Rajeshwari, Gormley, Nicole, Tang, Shenghui, Suzman, Daniel L, Amiri-Kordestani, Laleh, Kluetz, Paul G, Pazdur, Richard, Rini, Brian I, McDermott, David F, Regan, Meredith M

“…A clinically meaningful attribute of some immune-oncology (IO) regimens is potential durable clinical benefit during a treatment-free interval. We characterize…”
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An FDA Review of Drug Development in Nonmetastatic Castration-resistant Prostate Cancer by Brave, Michael, Weinstock, Chana, Brewer, Jamie R, Chi, Dow-Chung, Suzman, Daniel L, Cheng, Joyce, Zhang, Lijun, Sridhara, Rajeshwari, Ibrahim, Amna, Kluetz, Paul G, Pazdur, Richard, Beaver, Julia A

“…The FDA has approved three androgen receptor inhibitors-enzalutamide, apalutamide, and darolutamide-for the treatment of patients with nonmetastatic…”
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US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer by Heiss, Brian L, Chang, Elaine, Gao, Xin, Truong, Tien, Brave, Michael H, Bloomquist, Erik, Shah, Ankit, Hamed, Salaheldin, Kraft, Jeffrey, Chiu, Haw-Jyh, Ricks, Tiffany K, Tilley, Amy, Pierce, William F, Tang, Liuya, Abukhdeir, Abdelrahmman, Kalavar, Shyam, Philip, Reena, Tang, Shenghui, Pazdur, Richard, Amiri-Kordestani, Laleh, Kluetz, Paul G, Suzman, Daniel L

“…The US Food and Drug Administration (FDA) approved talazoparib with enzalutamide for first-line treatment of patients with homologous recombination repair…”
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U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review by Arora, Shaily, Narayan, Preeti, Ison, Gwynn, Berman, Tara, Suzman, Daniel L, Wedam, Suparna, Prowell, Tatiana M, Ghosh, Soma, Philip, Reena, Osgood, Christy L, Gao, Jennifer J, Shah, Mirat, Krol, Danielle, Wahby, Sakar, Royce, Melanie, Brus, Christina, Bloomquist, Erik W, Fiero, Mallorie H, Tang, Shenghui, Pazdur, Richard, Ibrahim, Amna, Amiri-Kordestani, Laleh, Beaver, Julia A

“…Over the last decade, there has been tremendous progress in the treatment of patients with gynecologic cancers with a changing therapy landscape. This summary…”
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Bone-targeting agents in prostate cancer by Suzman, Daniel L., Boikos, Sosipatros A., Carducci, Michael A.

“…Bone metastases are present in the vast majority of men with advanced prostate cancer, representing the main cause for morbidity and mortality. Recurrent or…”
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