Project Renewal FAQ
The FDA-approved prescribing information serves as the primary source of information for the safe and effective use of drugs. Project Renewal is a collaborative program that leverages external oncology experts to review publicly available data in the literature to update certain older oncology drug prescribing information to ensure this information is clinically meaningful and scientifically up to date.
Project Renewal is intended to help inform the provider community responsible for caring for cancer patients. This includes oncologists, advanced practice providers, registered nurses, and pharmacists at community and specialty pharmacies who use FDA prescribing information to inform clinical decisions and patient care. When applicable, revisions made to the prescribing information are also included in Patient Information, using nontechnical language to ensure safe and effective use.
Some older cancer drugs have prescribing information inconsistent with current regulations and guidance intended to make labeling more informative and easier to navigate. In addition to updating content with current scientific evidence, Project Renewal will ensure the prescribing information is in Physician Labeling Rule (PLR) and Pregnancy and Lactation Labeling Rule (PLLR) format. The PLR offers a consistent format for information that healthcare providers access, including dosage and administration, adverse reactions, drug interactions, and use in specific populations. The PLLR format includes information on the drug’s use during pregnancy and lactation, and in patients with reproductive potential.
- Scientific Expert Teams: Research teams are made up of external scientific experts who review the Project Renewal product's prescribing information and evaluate the publicly available evidence to determine what should be updated in the prescribing information.
- Fellows: Hematology and oncology fellows from academic training programs evaluate published literature and contribute to recommended updates to the prescribing information, while learning about FDA requirements for drug approval. This provides a unique "hands on" educational experience within the Project Renewal initiative.
- FDA: FDA staff participate in discussions with external oncologists to discuss the publicly available data for each drug and provide education on regulatory requirements for updating the prescribing information. Upon completion of evidence evaluation, the FDA team will conduct a full independent review of the proposed update recommendations and provide the final proposed prescribing information changes to the reference listed drug (RLD) holder.
- RLD Holders: Upon review of the FDA's proposed chances to the prescribing information, RLD holders will submit a supplemental application to their New Drug Application (NDA). RLD holders will be able to negotiate the final prescribing information during the supplemental application review period.
Project Renewal is focused on the evaluation of long-standing drugs with decades of clinical experience and use. Drugs on the market for over 20 years may not be in PLR/PLLR format, may have standard of care uses that are not included in the labeling or have outdated information. Many of these older drugs are important components of standard multi-agent chemotherapy regimens, some of which have curative potential. Project Renewal incorporates a standardized process of evaluating publicly available scientific information to support updates to the prescribing information, including potential new indications and dosage regimens. Several factors increase the acceptability of relying on published reports to support approval of a new use, including having multiple studies conducted by different investigators with consistent findings across studies, a high level of detail in the published reports (including statistical methods and analysis plans), appropriate endpoints that can be objectively assessed, robust results achieved by protocol-specified analyses, and studies conducted by research groups with a history of implementing high quality studies. Drugs selected for Project Renewal have decades of safety and other clinical data. Project Renewal is not intended for drugs approved in more recent years with more contemporary and relatively current prescribing information.
Multiple oncology drugs have been evaluated through Project Renewal and are in the various stages of independent FDA review and final supplement request preparation. The RLD holders will receive an official Prior Approval Supplement (PAS) request with the necessary information for their labeling updates.
Project Renewal Approvals
|Drug Name||Approval Date||Additional Resources|
|Xeloda (capecitabine)||December 14, 2022|