Today, the U.S. Food and Drug Administration issued a draft guidance, Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination, to describe for sponsors of certain oncology trials an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic (IVD) in a trial of investigational cancer drug or biological products is considered significant risk, non-significant risk, or exempt from further pre-market review.
Because many cancer treatments target a specific biomarker, IVDs are commonly used with cancer therapies to identify which patients have certain biomarkers and are therefore more likely to respond to treatment. In these cases, the companion diagnostic, a type of IVD, is required for the safe and effective use of the corresponding therapy.
Investigational IVDs and investigational drugs and biological products have different regulatory requirements. The process for determining whether an investigational IVD poses significant or non-significant risk to patients in a trial for an oncology therapy requires extensive coordination across different FDA product centers.
To reduce the administrative burden on sponsors and on FDA staff, the agency has issued draft guidance outlining circumstances under which sponsors may be able to include information about an investigational IVD in the Investigational New Drug (IND) application submission to the FDA center responsible for the therapeutic product (Center for Drug Evaluation and Research [CDER] or Center for Biologics Evaluation and Research [CBER]). This would allow the pre-market information related to the investigational drug and the investigational IVD to be contained in a single IND application.
Consolidating the information about both the investigational drug and device into the same application can enable more efficient review and help better establish the scientific relationship between the drug and the diagnostic being used to select patients for treatment. CDER or CBER would then coordinate with the FDA’s Center for Devices and Radiological Health to determine whether use of the investigational IVD in the trial is considered significant risk, non-significant risk, or exempt.