Advanced Therapies in Oncology: CAR-T Background, Supply Chain Considerations, and Recent FDA Insights

The exploitation of novel mechanisms of action and combination therapy opportunities, as well as a continuing drive towards personalized medicine through biomarkers and diagnostics, have significantly improved the standard of care in a number of oncology indications.
Nonetheless, novel therapeutic approaches – as opposed to molecular targets – have remained relatively infrequent, most often remained monoclonal antibodies and small molecules. Contemporaneously, though, several new approaches have reached the market in oncology; the subset of Chimeric Antigen Receptor T-cell (CAR-T) therapies is the subject of this paper.
The cellular therapy category has broached previously uncharted territory for both FDA (from a US regulatory perspective) and the developers who must meet emerging hurdles and demands.
This paper provides an overview of what makes these therapies unique compared to legacy biologics and what FDA’s actions to date on CAR-T therapies, in particular, suggest for future development.