The U.S. Food and Drug Administration (FDA) has launched a new voluntary pilot program aimed at improving the selection of cancer treatments for patients. The program focuses on certain oncology drug products used with corresponding in vitro diagnostic tests. These tests provide essential information for the safe and effective use of specific cancer treatments. The FDA has expressed concerns about the use of laboratory developed tests (LDTs) that have not been authorized by the FDA, as they may not provide accurate and reliable results. This can negatively impact treatment decisions.
Currently, the FDA may approve life-saving treatments that require the use of an in vitro companion diagnostic test, even if the corresponding test has not yet received marketing authorization. However, there are limitations on when this discretion is applied, such as during declared public health emergencies. LDTs have generally been under an enforcement discretion approach, meaning the FDA has not enforced many requirements or reviewed them for safety and effectiveness.
The pilot program aims to reduce the risk associated with using LDTs for oncology drug treatment decisions. It does this by requesting performance information from drug manufacturers about the tests used in clinical trials that support drug approval. Based on this assessment, the FDA will publish the minimum recommended performance characteristics for similar tests on their website. Laboratories can then use this information to develop LDTs that identify specific biomarkers for selecting cancer treatments. The aim is to improve the performance and consistency of these tests, leading to better drug selection and improved care for cancer patients.
The FDA’s Oncology Center of Excellence and the Office of Oncologic Diseases are committed to collaborating with the pharmaceutical industry and other stakeholders in addressing concerns and questions about the use of unauthorized diagnostics. The pilot program, which will last up to one year, will evaluate a maximum of nine drug sponsors for acceptance. The minimum recommended performance characteristics for in vitro diagnostic tests used with each approved drug product will be made publicly available on the FDA’s website after drug approval.
In summary, the FDA’s voluntary pilot program aims to improve the selection of cancer treatments by providing transparency and recommendations for diagnostic tests used in conjunction with certain oncology drugs. By requesting performance information from drug manufacturers and making it publicly available, the FDA hopes to reduce the risk associated with using non-FDA authorized tests and improve patient care. The program is expected to last one year and will involve up to nine drug sponsors.
