Gideon Michael Blumenthal MD

PubMed

• 1 citations
  US FDA's Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape f...
  Joseph M Gendy, Naomi Nomura, Jeffrey N Stuart, Gideon Blumenthal
  Therapeutic Innovation & Regulatory Science. 2024-03-01
• 5 citations
  The Association Between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients With Non-Small Cell Lung Cancer Treated With a PD-1/PD-L1 Blocking Antibo...
  Qi Liu, Raina Mathur, Yuan Xu, Aracelis Z Torres, Rebecca A Miksad
  Clinical Pharmacology and Therapeutics. 2023-05-01
• 8 citations
  Clinical Trial Diversity in Oncology: FDA Takes Action with Post-Marketing Requirements or Commitments.
  Janice Kim, Robert Kester, Gideon Blumenthal
  The Oncologist. 2022-12-09

Journal Articles

• Analysis of Time to Treatment Discontinuation of Targeted Therapy, Immunotherapy, and Chemotherapy in Clinical Trials of Patients with Non-Small Cell Lung Cancer  
  G R Oxnard, G M Blumenthal, P G Kluetz, R Pazdur, Annals of Oncology
• FDA Innovation Brings New Therapies to Lung Cancer Patients  
  Pazdur R, Blumenthal G, FDA Voice Blog, 5/5/2014
• Inside the Black Box: Molecularly Targeted Therapy for Lung Cancer  
  Blumenthal G, Mansfield E, The ASCO Post, 1/15/2014
• Management of Reproductive Health in Cowden Syndrome Complicated by Endometrial Polyps and Breast Cancer  
  Kalin A., Merideth M.A., Regier D.S., Blumenthal G.M., Dennis P.A., Stratton P, Obstet Gynecol, 1/1/2013
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Abstracts/Posters

• Second Cancers in Adults with Acute Promyelocytic Leukemia (APL) Treated with or without Arsenic Trioxide (ATO): A SEER-Medicare Analysis
  Gideon Blumenthal, 61st Annual American Society of Hematology Meeting, Orlando, FL, 12/8/2019
• Meta-analysis Results from the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC).
  Cortazar C, Zhang L, Untch M, Mehta K, Constantino J, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Zujewski J, Justice R, Loibl S, Wickerham L, Bogaerts J,..., General Session I, San Antonio Breast Cancer Symposium, 12/5/2012
• Sunitinib for the treatment of pancreatic neuroendocrine tumor (pNET)
  Blumenthal G.M., Oncologic Drug Advisory Committee, Silver Spring, MD, 4/12/2011
• Early targeted drug development: pilot FDA review of Pi3k inhibitor phase 1 studies using a knowledge management database.
  Blumenthal, G.M., Charlab Orbach R., Zineh I, Cortazar P, Justice R, Pazdur R, J Clin Oncol; General Poster Session, Developmental Therapeutics – Experimental Therapeutics, American Society of Clinical Oncology Annual Meeting, Chicago, IL, 1/1/2011
• FDA evaluation of hepatotoxicity related to tyrosine kinase inhibitors.
  Chang J., Rand M., Blumenthal G.M., Cortazar P., Kulick C., Hausman E., Chang S., Pratt R., Habtemarium B., Chen Y., Bullock J., Charlab Orbach R., Zineh I., Justice R..., J Clin Oncol; General Poster Session, Developmental Therapeutics – Experimental Therapeutics, American Society of Clinical Oncology Annual Meeting, Chicago, IL, 1/1/2011
• Key drug development features in the design of early-phase oncology trials: An FDA perspective.
  Charlab Orbach R., Blumenthal, G.M., Cortazar P, Filipski K.K., Zhang L., Mummaneni P., Booth B., Zineh I, J Clin Oncol; General Poster Session, Developmental Therapeutics – Clinical Pharmacology and Immunotherapy, American Society of Clinical Oncology Annual Meeting, Chicago, IL, 1/1/2011
• A Phase I/II trial of Pemetrexed and Sirolimus in advanced NSCLC.
  Blumenthal, G.M., Ballas M., Bernstein W., Shamloo K, Helsabeck C., Root H., Chun G., Figg W.D., Giaccone, G., Dennis P.A., J Clin Oncol; General Poster Session, Lung Cancer, American Society of Clinical Oncology Annual Meeting, Chicago, IL, 1/1/2010
• A Phase I Study of Nelfinavir, an FDA approved HIV protease inhibitor, in Adults with Refractory Solid Tumors.
  Dennis P.A, Blumenthal, G.M., Ballas M., Gardner E., LoPiccolo J., Kawabata S., Helsabeck C., Figg W.D., Bernstein W, J Clin Oncol; General Poster Session, Developmental Therapeutics, American Society of Clinical Oncology Annual Meeting, Orlando, FL, 1/1/2009
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Lectures

• Histologic-Agnostic Trials: Challenges and Opportunities—A Regulatory Perspective 
  ASCO Annual Meeting 2019 - Chicago, IL - 6/3/2019
• Analysis of Immune-Related Adverse Reactions in Patients with Classical Hodgkin Lymphoma (cHL) on Programmed Death-1 (PD-1) Inhibitor Therapy 
  2018 ASH Annual Meeting - San Diego, CA - 12/1/2018
• When don’t we need a phase III trial? 
  Chicago, IL - 5/1/2014
• Adaptive designs for exploratory, multi-drug multi-biomarker studies. 
  Bethesda, MD - 5/1/2014
• Center for Drug Evaluation and Research Perspective on master protocols and targeted therapy resistance in cancer. 
  Bethesda, MD - 5/1/2014
• Innovative trial designs to accelerate the availability of highly effective anti-cancer therapies: an FDA perspective. 
  San Diego, CA - 4/1/2014
• Evaluation of Oncology Drugs in Small Patient Populations: Challenges and Successes 
  Silver Spring, MD - 11/1/2013
• Overview of Breakthrough Therapies 
  Chicago, IL - 5/1/2013
• Breakthrough Therapies: FDA perspective. 
  Bethesda, MD - 5/1/2013
• Hepatotoxicty in Oncology Drug Development 
  College Park, MD - 3/1/2013
• American Course on Drug Development and Regulatory Sciences 
  University of California - 1/1/2013
• The Clinical Development of Inhibitors of the PI3K/AKT/mTOR Pathway 
  Baltimore, MD - 5/1/2012
• Future for Research in CardioOncology 
  Silver Spring, MD - 10/6/2011
• Clinical trial endpoints to support oncology drug approval. 
  Bethesda, MD - 5/1/2011
• Head and Neck Cancer 
  3/1/2011
• Accelerating Anticancer Agent Development and Validation Workshop (Faculty) 
  1/1/2011
• The clinical review of the I-SPY2 Trial in locally advanced breast cancer. 
  Silver Spring, MD - 12/3/2010
• Small Cell Lung Cancer 
  Bethesda, MD (Sep 2007) - 5/1/2008
• An Overview of Non Small Cell Lung Cancer 
  Bethesda, MD (Feb 2007) - 2/1/2008
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