OCE Cardio-Oncology Program

Purpose

The development of novel treatments has improved cancer outcomes but may result in cardiovascular toxicities. The Oncology Center of Excellence Cardio-Oncology Program promotes the development and evaluation of strategies to prevent, monitor, and manage cardiovascular complications associated with cancer therapies, with the goal of improving cardiovascular health and overall outcomes for patients with cancer and survivors.

Goals

• Improve patient outcomes by supporting strategies to monitor, prevent, and manage cardiovascular complications.
• Advance scientific research to better understand mechanisms of cardiovascular toxicity from cancer therapies.
• Promote the development and evaluation of cancer treatments that minimize cardiovascular risk while preserving oncologic efficacy.
• Enhance regulatory science by integrating cardiovascular safety considerations into oncology drug development and regulatory decision-making.
• Foster collaboration across academia, industry, and patient advocacy groups to advance cardio-oncology.
• Increase awareness and education among healthcare providers, researchers, and patients about the cardiovascular effects of cancer therapies.

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News and Events

• NEWLY PUBLISHED – FDA final guidance, "QTc Information in Human Prescription Drug Labeling," has recommendations for incorporating heart rate-corrected QT interval prolongation data into non-antiarrhythmic drug labels.
• Links to Cardio-Oncology Research funding opportunities for 3 award winners:
  • Cardio-Onco-AI: AI-Empowered Cardiotoxicity Risk Prediction Among Breast Cancer Survivors Using Multi-Site Real-World Data
  • AI-Enabled Echocardiographic Biomarkers and Real-World Data for Predicting Cancer Therapy-Related Cardiac Dysfunction
  • Metabolomic and Genetic Factors Decoupling Immune Checkpoint Inhibitor Tumor Efficacy and Cardiovascular Toxicity
• The CTCAE v 6 is now available on CTCAE and Adverse Event Reporting

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Select FDA Guidance Documents

• ICH E14 / S7B (QT/QTc Evaluation)
  • E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
  • E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers
  • S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
• QTc Labeling Guidance: QTc Information in Human Prescription Drug and Biological Product Labeling
• Oncology Dose Optimization (Project Optimus): Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
• Radiopharmaceutical Dose Optimization: Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development
• Patient-Focused Drug Development (PFDD): see FDA’s PFDD guidance page.
• IND Safety Reporting (21 CFR 312.32)
  • Safety-reporting guidance: Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies
• Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials
• Data Monitoring Committees (DMC / DSMB)
  • Establishment and Operation of Clinical Trial Data Monitoring Committees
  • Use of Data Monitoring Committees in Clinical Trials (draft)

Select Publications

• Cardiac Adverse Events in Patients Receiving Immune Checkpoint Inhibitors in the Adjuvant Setting: An FDA Pooled Analysis. Dilawari A, Krantz MJ, Bulatao I, Joeng HK, Neilson M, Wedam S, Gao X, Fiero MH, Nair A, Theoret M, Amiri-Kordestani L. Ann Noninvasive Electrocardiol. 2025 May;30(3):e70087. doi: 10.1111/anec.70087. PMID: 40343390
• Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer. Bonaca MP, Lang NN, Chen A, Amiri-Kordestani L, Lipka L, Zwiewka M, Strnadova C, Klaar S, Dent S, Janicijevic TK, Herrmann J, Barac A, de Boer RA, Deswal A, Schou M, Neilan TG, van der Meer P, Moslehi J, Kondapalli L, Ky B, Fernandez TL, Cornell RF, Flaig TW, Hsia J, Sharon E, de Azambuja E, Seltzer J, Januzzi JL, Petrie MC. JACC CardioOncol. 2025 Feb;7(2):83-95. doi: 10.1016/j.jaccao.2024.09.014. Epub 2024 Dec 10. PMID: 39967209
• To Adjudicate or Not Adjudicate: That Is the Question. Hicks KA, Fashoyin-Aje LA, Amiri-Kordestani L. JACC CardioOncol. 2022 Dec 20;4(5):657-659. doi: 10.1016/j.jaccao.2022.11.003. eCollection 2022 Dec. PMID: 36636434
• Arterial aneurysm and dissection with systemic vascular endothelial growth factor inhibitors: A review of cases reported to the FDA Adverse Event Reporting System and published in the literature. Cheng C, Nguyen MN, Nayernama A, Jones SC, Brave M, Agrawal S, Amiri-Kordestani L, Woronow D. Vasc Med. 2021 Oct;26(5):526-534. doi: 10.1177/1358863X211006470. Epub 2021 Apr 12. PMID: 33840328
• Assessing cardiac safety in oncology drug development. Seltzer JH, Gintant G, Amiri-Kordestani L, Singer J, Koplowitz LP, Moslehi JJ, Barac A, Yu AF. Am Heart J. 2019 Aug;214:125-133. doi: 10.1016/j.ahj.2019.04.010. Epub 2019 May 4. PMID: 31202099
• Myocarditis in the Setting of Cancer Therapeutics: Proposed Case Definitions for Emerging Clinical Syndromes in Cardio-Oncology. Bonaca MP, Olenchock BA, Salem JE, Wiviott SD, Ederhy S, Cohen A, Stewart GC, Choueiri TK, Di Carli M, Allenbach Y, Kumbhani DJ, Heinzerling L, Amiri-Kordestani L, Lyon AR, Thavendiranathan P, Padera R, Lichtman A, Liu PP, Johnson DB, Moslehi J. Circulation. 2019 Jul 2;140(2):80-91. doi: 10.1161/CIRCULATIONAHA.118.034497. PMID: 31390169; PMCID: PMC6779326.
• Cardio-Oncology: Vascular and Metabolic Perspectives: A Scientific Statement From the American Heart Association. Campia U, Moslehi JJ, Amiri-Kordestani L, Barac A, Beckman JA, Chism DD, Cohen P, Groarke JD, Herrmann J, Reilly CM, Weintraub NL.
• Myocarditis Associated with Immune Checkpoint Inhibitors: An Expert Consensus on Data Gaps and a Call to Action. Neilan TG, Rothenberg ML, Amiri-Kordestani L, Sullivan RJ, Steingart RM, Gregory W, Hariharan S, Hammad TA, Lindenfeld J, Murphy MJ, Moslehi JJ; Checkpoint Inhibitor Safety Working Group. Oncologist. 2018 Aug;23(8):874-878. doi: 10.1634/theoncologist.2018-0157. Epub 2018 May 25. PMID: 29802220
• 21st Century Cardio-Oncology: Identifying Cardiac Safety Signals in the Era of Personalized Medicine. Sheng CC, Amiri-Kordestani L, Palmby T, Force T, Hong CC, Wu JC, Croce K, Kim G, Moslehi J. JACC Basic Transl Sci. 2016 Aug;1(5):386-398. doi: 10.1016/j.jacbts.2016.05.008. PMID: 28713868

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• Meet the Program Lead

• Program Lead: Laleh Amiri-Kordestani, MD, Associate Director for Cardio-Oncology, Oncology Center of Excellence; and Director of Division of Oncology 1, Office of Oncologic Diseases, Center for Drug Evaluation and Research