Ag(e)nostic precision oncology therapy approvals across the years.

Abstract

Precision oncology leverages targetable molecular aberrations to treat cancer. Initially, use of these therapies required biomarker detection in a specific tumor type. Recently, regulatory agencies have approved highly active biomarker-based, tumor-agnostic therapies, which are crucial for the unmet needs of patients with rare cancer, including children with cancer, because an infrequent biomarker in an already rare cancer represents a prohibitive clinical trial accrual barrier. There are also now several 'ag(e)nostic' precision oncology therapies - agnostic to tumor type and also approved for all ages. In this opinion, we provide historical context for the precision oncology field and contend that, moving forward, ag(e)nostic precision oncology approvals should be the norm for this class of therapeutics rather than an exception to the rule.