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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.

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Fig. 1: Current pathways for FDA approval of companion diagnostic biomarkers for cancer therapies.


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The work of J.M.L. is supported by grants from the US NIH (RO1DK56621 and RO1DK128289), Cancer Research UK, Fondazione AIRC and Fundación Científica de la Asociación Española Contra el Cáncer (HUNTER, ref. C9380/A26813), the Samuel Waxman Cancer Research Foundation, Generalitat de Catalunya (AGAUR, SGR-1358), and the Spanish National Health Institute (MICINN, PID2019-105378RB-I00).

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Correspondence to Josep M. Llovet.

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J.M.L. has received research support from Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Eisai and Ipsen, and consulting fees from AstraZeneca, Bayer HealthCare Pharmaceuticals, Bluejay Therapeutics, Boston Scientific, Bristol Myers Squibb, Captor Therapeutics, Eisai, Eli Lilly, Exelixis, Genentech, Glycotest, Ipsen, Merck, Mina Alpha, Omega Therapeutics and Roche.

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Llovet, J.M. Exploring a new pathway for biomarker-based approval of immunotherapies. Nat Rev Clin Oncol (2023).

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