LalehAmiri KordestaniMD

PubMed

• Efficacy of Poly(ADP-ribose) Polymerase Inhibitors by Individual Genes in Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer:...
  Jaleh Fallah, Jianjin Xu, Chana Weinstock, Xin Gao, Brian L Heiss, William F Maguire, Elaine Chang, Sundeep Agrawal, Shenghui Tang, Laleh Amiri-Kordestani, Richard Paz...> ;Journal of Clinical Oncology. 2024 Mar 14
• Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a U.S. FDA pooled analysis.
  Jaleh Fallah, Haley Gittleman, Chana Weinstock, Elaine Chang, Sundeep Agrawal, Shenghui Tang, Richard Pazdur, Paul G Kluetz, Daniel L Suzman, Laleh Amiri-Kordestani> ;Journal of the National Cancer Institute. 2024 Mar 14
• US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Muta...
  Brian L Heiss, Elaine Chang, Xin Gao, Tien Truong, Michael H Brave, Erik Bloomquist, Ankit Shah, Salaheldin Hamed, Jeffrey Kraft, Haw-Jyh Chiu, Tiffany K Ricks, Amy Ti...> ;Journal of Clinical Oncology. 2024 Mar 7
• FDA Approval Summary: Enfortumab Vedotin Plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma.
  Maguire, W., Lee, D., Weinstock, C., Gao, X., Bulik, C., Agrawal, S., Chang, E., Hamed, S., Bloomquist, E., Tang, S., Pazdur, R., Kluetz, P., Suzman, D., Amiri-Kordest...> ;Clinical Cancer Research. 2024 Mar 5
• A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma.
  Chang, E., Zhou, J., Song, C., Gittleman, H., Fernandes, L., Weinstock, C., Atkins, M., Agrawal, S., Sridhara, R., Gormley, N., Tang, S., Suzman, D., Amiri-Kordestani,...> ;Clinical Cancer Research. 2024 Feb 28
• 1 citations
  US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative,-Mutated Advanced or Me...
  Mirat Shah, Hima Lingam, Xin Gao, Haley Gittleman, Mallorie H Fiero, Danielle Krol, Nikolett Biel, Tiffany K Ricks, Wentao Fu, Salaheldin Hamed, Fang Li, Jillian Jieli...> ;Journal of Clinical Oncology. 2024 Apr 1
• 1 citations
  FDA Approval Summary: Olaparib in Combination With Abiraterone for Treatment of Patients With-Mutated Metastatic Castration-Resistant Prostate Cancer.
  Fallah, J., Xu, J., Weinstock, C., Brave, M., Bloomquist, E., Fiero, M., Schaefer, T., Pathak, A., Abukhdeir, A., Bhatnagar, V., Chiu, H., Ricks, T., John, C., Hamed, ...> ;Journal of Clinical Oncology. 2024 Feb 10
• Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development.
  Donaldson, J., Joshua M Donaldson, Marjilla Seddiq, Michael J Fusco, Shyamli Singla, Gulsum E Pamuk, Rosa J Lee-Alonso, Bronwyn D Mixter, Kirsten B Goldberg, Laleh Ami...> ;Cancer Discovery. 2023 Dec 12
• 1 citations
  Methodology for Good Machine Learning with Multi-Omics Data.
  Thibaud Coroller, Berkman Sahiner, Anup Amatya, Alexej Gossmann, Konstantinos Karagiannis, Conor Moloney, Ravi K Samala, Luis Santana-Quintero, Nadia Solovieff, Craig ...> ;Clinical Pharmacology and Therapeutics. 2024 Apr 1
• 8 citations
  FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer.
  Asma Dilawari, Mirat Shah, Gwynn Ison, Haley Gittleman, Mallorie H Fiero, Ankit Shah, Salaheldin S Hamed, Junshan Qiu, Jingyu Yu, Wimolnut Manheng, Tiffany K Ricks, Ra...> ;Clinical Cancer Research. 2023 Oct 2
• FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.
  Christy L Osgood, Zhou Feng, Erik W Bloomquist, Shenghui Tang, C J George Chang, Tiffany K Ricks, Sherry C Hou, William F Pierce, Donna R Rivera, Laleh Amiri-Kordestan...> ;Clinical Cancer Research. 2023 Dec 15
• 4 citations
  Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials: NeoSTEEP.
  Jennifer K Litton, Meredith M Regan, Lajos Pusztai, Hope S Rugo, Sara M Tolaney, Elizabeth Garrett-Mayer, Laleh Amiri-Kordestani, Reva K Basho, Ana F Best, Jean-Franco...> ;Journal of Clinical Oncology. 2023 Sep 20
• 1 citations
  US Food and Drug Administration Expanded Adjuvant Indication of Abemaciclib in High-Risk Early Breast Cancer.
  Melanie Royce, Flora Mulkey, Christy Osgood, Erik Bloomquist, Laleh Amiri-Kordestani> ;Journal of Clinical Oncology. 2023 Jun 20
• 2 citations
  A U.S. Food and Drug Administration-pooled Analysis of Frontline Combination Treatment Survival Benefits by Risk Groups in Metastatic Renal Cell Carcinoma.
  Daniel Lee, Haley Gittleman, Chana Weinstock, Daniel Suzman, Erik Bloomquist, Sundeep Agrawal, Michael Brave, Jamie Brewer, Jaleh Fallah, Harpreet Singh, Shenghui Tang...> ;European Urology. 2023 Oct 1
• 1 citations
  The Development of the Oncology Center of Excellence Patient-Friendly Language Glossary of Oncology Clinical Trial Terms.
  Danielle Krol, Janice Kim, Jennifer Gao, Laleh Amiri-Kordestani, Julia A Beaver, Paul Kluetz> ;The Oncologist. 2023 May 8
• 18 citations
  US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Ca...
  Preeti Narayan, Asma Dilawari, Christy Osgood, Zhou Feng, Erik Bloomquist, William F Pierce, Samina Jafri, Shyam Kalavar, Marina Kondratovich, Prakash Jha, Shenghui Ta...> ;Journal of Clinical Oncology. 2023 Apr 10
• 12 citations
  Use of Single-Arm Trials for US Food and Drug Administration Drug Approval in Oncology, 2002-2021.
  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, Har...> ;JAMA Oncology. 2023 Feb 1
• 3 citations
  FDA Approval Summary: Belzutifan for VHL Disease Tumors-Response.
  Jaleh Fallah, Chana Weinstock, Gautam U Mehta, Michael H Brave, William F Pierce, Richard Pazdur, Abhilasha Nair, Daniel L Suzman, Laleh Amiri-Kordestani> ;Clinical Cancer Research. 2023 Feb 1
• 9 citations
  FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer.
  Mirat Shah, Christy L Osgood, Anup K Amatya, Mallorie H Fiero, William F Pierce, Abhilasha Nair, Jonathan Herz, Kim J Robertson, Bronwyn D Mixter, Shenghui Tang, Richa...> ;Clinical Cancer Research. 2022 Dec 15
• 24 citations
  FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer.
  Jaleh Fallah, Sundeep Agrawal, Haley Gittleman, Mallorie H Fiero, Sriram Subramaniam, Christy John, Wei Chen, Tiffany K Ricks, Gang Niu, Anthony Fotenos, Min Wang, Kel...> ;Clinical Cancer Research. 2023 May 1
• To Adjudicate or Not Adjudicate: That Is the Question.
  Karen A Hicks, Lola A Fashoyin-Aje, Laleh Amiri-Kordestani> ;JACC. Cardiooncology. 2022 Dec 1
• 32 citations
  FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease-Associated Tumors.
  Jaleh Fallah, Michael H Brave, Chana Weinstock, Gautam U Mehta, Diana Bradford, Haley Gittleman, Erik W Bloomquist, Rosane Charlab, Salaheldin S Hamed, Claudia P Mille...> ;Clinical Cancer Research. 2022 Nov 14
• 22 citations
  Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients.
  Jeanne Fourie Zirkelbach, Mirat Shah, Jonathon Vallejo, Joyce Cheng, Amal Ayyoub, Jiang Liu, Rachel Hudson, Rajeshwari Sridhara, Gwynn Ison, Laleh Amiri-Kordestani, Sh...> ;Journal of Clinical Oncology. 2022 Oct 20
• 17 citations
  FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.
  Melanie Royce, Christy L Osgood, Anup K Amatya, Mallorie H Fiero, C J George Chang, Tiffany K Ricks, Krithika A Shetty, Jeffrey Kraft, Junshan Qiu, Pengfei Song, Rosan...> ;Clinical Cancer Research. 2022 Apr 14
• 32 citations
  FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer.
  Melanie Royce, Christy Osgood, Flora Mulkey, Erik Bloomquist, William F Pierce, Arpita Roy, Shyam Kalavar, Reena Philip, Fatima Rizvi, Bronwyn D Mixter, Shenghui Tang,...> ;Journal of Clinical Oncology. 2022 Apr 10
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