WHAT IS PROJECT RENEWAL?
Project Renewal is a public health initiative established by the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) that aims to update the labeling information for oncology products by evaluating relevant scientific evidence from published literature.
This initiative established a set of repeatable processes and procedures to inform regulatory decisions for oncology product labeling updates, including potential new indications for use.
Aligned with the FDA’s mission to protect public health, this initiative is an opportunity to transparently collaborate with external stakeholders in the evaluation of scientific evidence to inform clinical decisions and patient care.
WHY IT STARTED
Patients and healthcare providers rely on accurate labeling for care and treatment decisions. However, many oncology products on the market today have outdated labeling, despite new information coming available in the post-marketing setting that could support labeling changes, including updated indications for use.
Project Renewal is working to address this public health challenge of outdated product labeling by establishing a set of processes and procedures to inform regulatory decisions for oncology product labeling updates, including potential updated indications for use.
Labeling updates made under Project Renewal are intended to provide updated evidence to inform safe and effective use of oncology products.
Develop Repeatable Processes
Use Published Data
Engage with Oncology Community
Foster Educational Experiences
The FDA product label is the primary source of information for the safe and effective use of cancer drugs. Product labels can become outdated over time as new information is learned. Some of this information may not be added to the product label by the New Drug or Biologics License Application holder, for a variety of reasons. Project Renewal aims to create a collaborative, scientifically rigorous and efficient process to review and update the product labels for several longstanding, commonly used cancer drugs.
Project renewal is intended to help inform the provider community responsible for caring for cancer patients. This includes oncologists (MDs), advanced practice providers (APPs), registered nurses (RNs), and pharmacists at community and specialty pharmacies who use FDA product labeling to access the most current information about the drug to inform patient care.
OCE conducted structured interviews with healthcare providers in the oncology community to gain a better understanding of their awareness regarding FDA-approved oncology labeling. Providers were asked what other sources of product information they use and how access to these sources may differ depending on their practice settings. This work informs OCE’s role in contributing to broader FDA efforts to improve the content, access and use of FDA product labeling.
FDA product labeling provides critical information on the safe and effective use of cancer drugs. Project Renewal has been initiated to assure that the most up to date information on safe and effective use is included in the labels of a set of important cancer drugs that have formed the backbone for many standard of care cancer treatments for decades.
Project Renewal is also investigating ways to improve the access to- and use of product labeling through digital solutions in order to better meet the needs of healthcare providers. This includes continuing to educate healthcare providers on what FDA labeling is, how it is generated, and how to easily locate important scientifically rigorous information in the label to guide exceptional cancer care.
Some older cancer drugs have product labels that are not in the most current standard format known as the “Physician Labeling Rule (PLR)”. The PLR format was created to create a standard organized format that can allow healthcare providers to rely on a consistent location for information that they need to access, including dosage and administration, adverse reactions, drug interactions, and specific population information. In addition to updating content with current scientific evidence, Project Renewal will ensure labels are in PLR format and adhere to the most up to date FDA guidance for effective and informative labeling.
A key objective of Project Renewal is to engage the oncology community to assist FDA’s labeling update process through identification and evaluation of accumulated scientific evidence from the published literature. Project Renewal adds value to our responsibility to update product labels by offering a range of external clinical and scientific collaborators the opportunity to work with FDA and gain an understanding of product labeling and evidence evaluation.
The OCE held five workshops in 2018 to identify and prioritize approximately 40 commonly used, long-standing oncology products for review through Project Renewal. Several product labels have undergone the Project Renewal evidence evaluation process and will complete independent FDA review in 2020. As the process is refined, efficiencies may be created, allowing research teams to evaluate publicly available data for multiple products at one time. The program will be re-evaluated after a 3-year pilot phase.
Project Renewal will evaluate product labeling for drugs approved several decades ago, that are not in PLR format or where there are other scientific data or significant off-label use supported by substantial evidence in the U.S. oncology community. Most drugs in the Project Renewal pilot are important components of standard multi-agent cytotoxic chemotherapy regimens, some of which have curative potential. Project Renewal uses an uncommon approach to support potential new indications and dosage regimens by relying on available published literature. The use of published data is acceptable in this context where there is decades of post-marketing safety data, multiple clinical studies and a context where conduct of clinical trials may not be feasible. The Project Renewal process is not expected to be used for contemporary product approval or indication expansion given the less robust post-marketing safety experience of recently approved drugs and the wider availability of digital records for patient-level datasets collected under prospective clinical protocols performed in the current drug development era.