At a forum convened by Friends of Cancer Research in September 2013, a panel of experts presented five proposals outlining how sponsors and FDA may be able to improve and expedite the process for the codevelopment and review of a companion diagnostic designed for use with a drug that has received the FDA’s Breakthrough Therapy designation. The proposals included:
1. Automatic designation of in vitro companion diagnostic devices for use as part of a Breakthrough Therapy drug approval as eligible for priority review
2. Use of highly coordinated administrative processes and management commitments for the review of in vitro companion diagnostics associated with Breakthrough Therapies that are commensurate with those processes offered for Breakthrough Therapies
3. Use of risk-based processes to determine required analytic studies for each assay at time of premarket approval filing
4. Use of risk-based approaches to determine requirements for data and testing related to quality systems, manufacturing processes, and software testing and documentation
5. Use of a Continued Access investigational device exception supplement to enable a broader set of laboratories to be ready for testing immediately upon contemporaneous approval of the companion diagnostic and therapeutic product. ■
A companion diagnostic developed for use with a drug that has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) should automatically be eligible for priority review, according to an expert panel that presented this proposal and four others to the FDA in...