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Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review

In 2018, the FDA approved 19 new drug and biologic applications, 38 supplemental drug and biologic applications and 4 biosimilar applications in oncology. These advances in anticancer therapy included a landmark approval of the first histology-agnostic, biomarker-defined new molecular entity and approvals based on real-time data review and novel end points, such as minimal residual disease rate and metastasis-free survival.

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Fig. 1: FDA haematology–oncology (cancer) drug approvals in 2018.


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The authors thank K. Goldberg for her assistance in editing this manuscript.

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Correspondence to Gideon M. Blumenthal.

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Blumenthal, G.M., Pazdur, R. Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review. Nat Rev Clin Oncol 16, 139–141 (2019).

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