FDA and AACR Launch Project Livin’ Label
PHILADELPHIA – The American Association for Cancer Research (AACR) and the U.S. Food and Drug Administration (FDA) will collaborate on Project Livin’ Label, a new educational initiative that aims to foster broad understanding of specific oncology product labels and increase awareness of recent oncology drug FDA approvals among physicians, cancer patients and survivors, industry representatives, and others.
For each oncology product to be featured as part of this initiative, the FDA’s Oncology Center of Excellence (OCE) will moderate a panel discussion to include the FDA reviewer(s), a clinical trial investigator from academia, a patient who has benefited from the therapy, and a representative from the company that developed the drug. This interaction about the product’s development and the FDA’s review process will provide essential information for the safe and effective use of the product.
“As part of its mission, the Oncology Center of Excellence leads several initiatives to educate oncologists about the FDA’s role in drug development,” said Richard Pazdur, MD, director, FDA Oncology Center of Excellence. “Project Livin’ Label aims to bring together participants for an informal discussion of the backstory of how drugs were developed and ultimately approved. We hope these discussions will provide a stimulating educational experience for the oncology community, and we are fortunate to partner with the AACR to offer these free broadcasts.”
The first episode, moderated by Pazdur, discusses the story behind the April 17, 2020, approval of tucatinib. The OCE will select the oncology products featured in future episodes based on certain attributes that illustrate key issues in the development and review of each oncology product.
“The AACR is proud to partner with the FDA’s Oncology Center of Excellence on another exciting and innovative initiative, Project Livin’ Label,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “This new educational initiative will help clinicians and patients become more familiar with the oncology drug label, including how to better understand the dosing requirements and familiarize themselves with any concerns about the side effects that are associated with a particular therapy. Additionally, it is an opportunity to learn important background information from all of the relevant stakeholders about a particular drug that promises to make a major difference for patients with cancer.”
These panel discussions will be recorded and broadcast on demand via the AACR’s myAACR platform, through which health care professionals who attend can claim Continuing Medical Education (CME) credit. The videos will be free to view.
Project Livin’ Label is an educational initiative and not intended to promote any one oncology product over another. Selection for inclusion in Project Livin’ Label does not constitute an endorsement by the FDA or the AACR for use of that oncology product. To learn more about Project Livin’ Label, visit the AACR website.