Approvals in 2017: gene therapies and site-agnostic indications

Approvals in 2017: gene therapies and site-agnostic indicationsApprovals in 2017: gene therapies and site-agnostic indications, Published online: 31 January 2018; doi:10.1038/nrclinonc.2018.11In 2017, FDA Oncology approved 17 new drug and biologic applications, 32 supplemental drug and biologic applications, and two biosimilar applications in oncology. These actions included landmark approvals of two chimeric antigen receptor T cell therapies and the first site-agnostic, biomarker-defined approval. Three next-generation sequencing 'oncopanels' designed to detect hundreds of somatic genetic aberrations were also approved.
Source: Nature Clinical Practice Oncology - Category: Cancer & Oncology Authors: Source Type: research