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Project Livin’ Label

A collaboration between FDA’s Oncology Center of Excellence and the American Association for Cancer Research

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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 
    • 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
    • 1.5 CME Credits will be awarded for watching the episode and reviewing the tucatinib USPI
Start Activity
  • Episode 2 – Pemigatinib: The Backstory 
    • 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
  • Speaker Biographies
  • Pemigatinib Prescribing Information
  • 1.5 CME Credits will be awarded for watching the episode and reviewing the pemigatinib USPI
Start Activity
  • Episode 3 – Osimertinib: The Backstory
    • 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
  • 1.5 CME Credits will be awarded for watching the episode and reviewing the osimertinib USPI
start activity

Episode 4 – DARA SC + CyBorD: The Backstory

  • 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
start activity

Episode 5 – Venetoclax: The Backstory

  • 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
start activity

Continuing Medical Education Activity AMA PRA Category 1 CreditsTM available

Have suggestions for future Project Livin’ Label content? Submit it here!

Additional Information