Targeted Therapy Approvals: Summary And Future Directions.

e22181 Background: The development of targeted therapies for cancer has thrived with improved understanding of genetic mechanisms and co-development of companion diagnostics. Methods: Clinical trials leading to new drug and new indication approvals were reviewed. Results: The Table below summarizes the targeted therapies for cancer approved by the FDA. Approvals in the last three years are in marker with an asterisk. Conclusions: Identification of molecular targets early in drug development has enabled the co-development of commercial tests. Despite these recent successes, challenges remain. Future development of targeted therapies will need to explore different trial designs across tumor subtypes, continue co-development of companion diagnostics, and integrate combination therapies to better take into account molecular pathways of disease. FDA perspectives and recent developments will be presented. Primary molecular target Approved therapies Indication FDA-approved diagnostic (+ co-approved with dx) ALK ...