Project Livin’ Label
A collaboration between FDA’s Oncology Center of Excellence and the American Association for Cancer Research
What is Project Livin’ Label?
Oncology product labels contain essential information needed for their safe and effective use. However, many are unfamiliar with the product labels, what information is contained in them, and how to use them. Project Livin’ Label is a new educational initiative that aims to foster broad understanding of the associated oncology product label and increase awareness of recent oncology drug FDA approvals in the cancer community.
Using oncology product labeling as a road map, the FDA’s Oncology Center of Excellence (OCE) will guide discussions between an FDA reviewer, a clinical trial investigator, a patient, and the company on the backstory of the oncology product development and FDA review process.
Join us as the OCE highlights select cancer therapeutics clinical development programs and releases knowledge about the oncology products’ clinical journey from development to approval.
Who is the Target Audience?
Our primary audience includes physicians, other health care providers, cancer survivors, patients, advocates, families, industry, and others who are seeking to better understand cancer therapy development. For health care professionals, the AACR is providing Continuing Medical Education (CME) credit.
How Will FDA Select Which Products to Highlight?
The FDA is selecting products based on certain attributes of their development program. These attributes will illustrate key issues in the development and review of each oncology product, and details will be discussed in each webinar.
Project Livin’ Label is an educational initiative. Project Livin’ Label is not intended to promote any one oncology product over another, nor does it constitute an endorsement by FDA or AACR for use of that oncology product.
Why Are FDA and AACR Working Together?
The OCE and AACR have complementary missions. Each organization relies on the expertise of hematologists, oncologists, and scientists that are well-trained on the fundamentals of oncology products. This educational collaboration will help to provide insight and transparency into the approvals of selected FDA oncology products.
ON-DEMAND WEBINARS
INSTRUCTIONS
- Click “Start Activity” below.
- Click the “Register” button in the new tab.
- Complete the registration process.
- Check your email for a link to the content.
Introduction to Project Livin’ Label
EPISODES
Episode 1 – Tucatinib: The Backstory – CME expired (Oct. 3, 2023)
- In This Episode:
- Richard Pazdur, MD, Director, FDA Oncology Center of Excellence
- Suparna Wedam, MD, Physician, FDA Office of Oncologic Drugs, Division of Oncology 1
- Luke Walker, MD, Global Development Lead, Tucatinib and Vice President, Clinical Development at Seattle Genetics
- Nancy Lin, MD, Associate Chief, Division of Breast Oncology, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute
- Sandy Weaver, Trial Participant on HER2CLIMB Clinical Trial
- Ulrich Rohr, MD, Deputy Head of Division Clinical Review, SwissMedic
- Speaker Biographies
- Tucatinib Prescribing Information
Episode 2 – Pemigatinib: The Backstory – CME expired (Dec. 16, 2023)
- In This Episode:
- Richard Pazdur, MD, Director, FDA Oncology Center of Excellence
- Tanios Bekaii-Saab, MD, FACP, Leader, Gastrointestinal Cancer Program, Mayo Clinic Cancer Center
- Lola A. Fashoyin-Aje, MD, MPH, Deputy Division Director, Division of Oncology 3, FDA
- Peter Langmuir, MD, Group Vice President of Oncology Targeted Therapies, Incyte
- Stacie Lindsey, CEO, Cholangiocarcinoma Foundation
- Andrea Parrella, Trial Participant on FIGHT-202 Clinical Trial
Episode 3 – Osimertinib: The Backstory – CME expired (Mar. 5, 2024)
- In This Episode
- Richard Pazdur, MD, Director, FDA Oncology Center of Excellence
- Jill Feldman, Lung Cancer Patient and Advocate, Co-Founder of EGFR Registers
- Roy Herbst, MD, PhD, Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital
- Yuri Rukazenkov, MD, PhD, Global Clinical Lead, Oncology, AstraZeneca
- Harpreet Singh, MD, Director, Division of Oncology 2, FDA
- Speaker Biographies
- Osimertinib Prescribing Information
Episode 4 – DARA SC + CyBorD: The Backstory – CME expired (Apr. 20, 2024)
- In This Episode
- Nicole Gormley, MD, Director, Division of Hematologic Malignancies II, FDA
- B Amore, Trial Participant on AMY3001 Clinical Trial.
- Raymond Comenzo, MD, Director, John C. Davis Program in Myeloma and Amyloidosis, Tufts Medical Center
- Bindu Kanapuru, MD, Medical Officer, Division of Hematologic Malignancies II, FDA
- Jessica Vermeulen, MD, PhD, Vice President, Clinical Research and Development, Janssen
Episode 5 – Venetoclax: The Backstory – CME expired (Jul. 19, 2024)
- In This Episode:
- Kelly Norsworthy, MD, Team Leader, Division of Hematologic Malignancies I, FDA
- Courtney DiNardo, MD, Associate Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
- Lori Ehrlich, MD, PhD, Medical Officer, Division of Hematologic Malignancies I, FDA
- Jalaja Potluri, MD, FACP, Executive Medical Director, AbbVie
- Claude Sipe, Clinical Trial Participant
Episode 6 – Tivozanib: The Backstory – CME expired (Aug. 26, 2024)
- In This Episode:
- Chana Weinstock, MD –Team Leader, Genitourinary Cancers Team, Division of Oncology 1, FDA
- Elaine Chang –Medical Officer, Division of Oncology 1, FDA
- Michael Needle, MD –Chief Medical Officer, AVEO
- Brian Rini, MD, FASCO –Professor of Medicine, Chief of Clinical Trials, Vanderbilt-Ingram Cancer Center
- B. George Bufkin, PhD –Clinical Trial Participant
Episode 7 – Pembrolizumab: The Backstory
- In This Episode:
- Jennifer Gao, MD – Associate Director for Education, Oncology Center of Excellence, FDA
- Mirat Shah, MD – Physician, Division of Oncology 1, FDA
- Vassiliki Karantza, MD – Associate Vice President, Global Clinical Development, Merck
- Heather McArthur, MD – Clinical Director of Breast Cancer, University of Texas Southwestern Medical Center
- Demetria Lam – Patient
- Sandra Cuellar Puri, PharmD – Clinical Associate Professor, Department of Pharmacy Practice, University of Illinois at Chicago College of Pharmacy
- Speaker Biographies
- Pembrolizumab Prescribing Information
- 1.5 CME Credits or 1.5 NCPD credits will be awarded for watching the episode and reviewing the pembrolizumab USPI
Episode 8 – Sotorasib: The Backstory
- In This Episode:
- Nicole Drezner, MD – Team Leader, Division Oncology 2, FDA
- Erica Nakajima, MD – Physician, Division Oncology 2, FDA
- Stacy Shord, PharmD – Deputy Division Director, Division of Cancer Pharmacology II · FDA
- Greg Friberg, MD – Vice President, Medical Affairs for Europe, Latin America, Middle East, Africa and Canada, Amgen, Inc.
- Grace K. Dy, MD – Chief, Division of Thoracic Oncology, Department of Medicine, Roswell Park Center Institute
- John A. Szczesny – Patient
- Askia Dozier, RN – Clinical Research Nurse Coordinator III, Roswell Park Center Institute
- Speaker Biographies
- Sotorasib Prescribing Information
- 1.5 CME Credits will be awarded for watching the episode and reviewing the sotorasib USPI
Episode 9 – Neo-adjuvant Nivolumab: The Backstory
- In This Episode:
- Jeevan Puthiamadathil, MD – Oncologist, Division of Oncology 2, FDA
- Oladimeji Akinboro, MD – Oncologist, Division of Oncology 2, FDA
- Abderrahim Oukessou, MD – Vice President, Development Program Lead, Oncology, Bristol-Myers Squibb
- Patrick Forde, MD – Johns Hopkins University, Clinical Investigator
- Dawn Vasco – Patient
- Kevin Chen, PharmD – University of North Carolina Medical Center, Pharmacist
- Speaker Biographies
- Neo-adjuvant Nivolumab Prescribing Information
- 1.5 CME Credits or 1.5 NCPD credits will be awarded for watching the episode and reviewing the neo-adjuvant nivolumab USPI
Episode 10 – Ivosidenib: The Backstory
- In This Episode:
- Kelly Norsworthy, MD, Deputy Division Director, Division of Hematologic Malignancies 1, Office of Oncologic Diseases, FDA Center for Drug Evaluation and Research
- Ashley Woods, MD, Hematologist, Division of Hematologic Malignancies 1, Office of Oncologic Diseases, FDA Center for Drug Evaluation and Research
- Susan Pandya, MD, Vice President, Clinical Development, Head of Cancer Metabolism Global Division, Servier Pharmaceuticals
- Stéphane de Botton, MD, PhD, Physician, Clinical Investigator, Head of Hematology, Gustave Roussy Cancer Center
- Amir Fathi, MD, Director of Leukemia Program, Massachusetts General Hospital
- Aura Ramos, RN, BSN, Research Nurse, Massachusetts General Hospital
- Matthew Newman, PharmD, Oncology Pharmacist, Johns Hopkins University
- Lucille Giunta, Patient and Clinical Trial Participant
- Speaker Biographies
- Ivosidenib Prescribing Information
- 1.5 CME Credits or 1.5 NCPD credits will be awarded for watching the episode and reviewing the ivosidenib USPI
Episode 11 – fam-Trastuzumab Deruxtecan-nxki: The Backstory
- In this episode:
- Preeti Narayan, MD, Breast and Gynecologic Malignancies Team Lead, Division of Oncology 1, Office of Oncologic Diseases, U.S. Food and Drug Administration (FDA)
- Asma Dilawari, MD, Oncologist and Clinical Reviewer, Division of Oncology 1, Office of Oncologic Diseases, FDA
- Gerold Meinhardt, MD, PhD, Global Team Lead for fam-trastuzumab deruxtecan-nxki, Daiichi Sankyo, Inc.
- Naoto T. Ueno, MD, PhD, FACP, Director of University of Hawaii Cancer Center
- Kasey Hoggatt, Patient and Clinical Trial Participant
- Debora (Debbie) Geary, MS, BSN, RN, OCN, CCRP, Research Nurse Specialist Sylvester Comprehensive Cancer Center at University of Miami Health System
- Neha Mangini, PharmD, BCOP, Clinical Oncology Pharmacist, Breast Oncology, Huntsman Cancer Institute
- Speaker Biographies
- fam-Trastuzumab Deruxtecan-nxki Prescribing Information – 1.5 CME Credits or 1.5 NCPD credits will be awarded for watching the episode and reviewing the fam-Trastuzumab Deruxtecan-nxki USPI
Episode 12 – Tebentafusp-tebn: The Backstory
- In this episode:
- Timil Patel, MD, Medical Oncologist, Division of Oncology 3, Oncology Center of Excellence, FDA
- Jamie Brewer, MD, Medical Oncologist and Acting Clinical Team Lead, Division of Oncology 3, Office of Oncologic Diseases, FDA
- Mark Moyer, Senior Vice President, Head of Regulatory Sciences, Immunocore
- Richard D. Carvajal, MD, Deputy Physician-in-Chief, Director of Hematology/Oncology, Northwell Health Cancer Institute
- Jianan (Carlos) Sheng, Patient and Clinical Trial Participant
- Carol Ann Wiggs, Clinical Research Nurse Manager, Duke Cancer Institute
- Heather Armbruster, PharmD, BCOP, Outpatient Clinical Pharmacy Manager, James Cancer Hospital & Solove Research Institute
- Speaker Biographies
- Tebentafusp-tebn Prescribing Information – CME credits, NCPD credits, and CPE hours will be awarded for watching the episode and reviewing the tebentafusp-tebn USPI
Continuing Medical Education Activity AMA PRA Category 1 CreditsTM available
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