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

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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… Click to show full abstract

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.

Keywords: real time; histology agnostic; new molecular; molecular entity; oncology; histology

Journal Title: Nature Reviews Clinical Oncology
Year Published: 2019

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