Exploring a new pathway for biomarker-based approval of immunotherapies

The revolution of immunotherapies in oncology has not been matched by the development of companion diagnostic biomarkers able to identify the ideal target populations. Aside from the established pathways for regulatory approval relying on predefined biomarkers, a novel approach based on post hoc biomarker analysis could potentially be instrumental in enhancing the cost-effectiveness of cancer immunotherapy.

Automated summary

The rapid progress of immunotherapy revolution in oncology lacks the development of companion diagnostic biomarkers to identify ideal target populations. In addition to the established regulatory pathways relying on predefined biomarkers, a novel approach based on post hoc biomarker analysis could significantly enhance the cost-effectiveness of cancer immunotherapy.