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

Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time reviewApprovals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review, Published online: 22 January 2019; doi:10.1038/s41571-019-0170-zIn 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.

Source: Nature Clinical Practice Oncology - January 22, 2019 Category: Cancer & Oncology Authors: Gideon M. Blumenthal Richard Pazdur Source Type: research