A reality check of the accelerated approval of immune-checkpoint inhibitors

Nature Reviews Clinical Oncology, Published online: 05 August 2019; doi:10.1038/s41571-019-0260-yThe FDA grants Accelerated Approval when deemed necessary to address an unmet need, with a promise that post-marketing research commitments will be fulfilled and that the approvals will be revisited and eventually changed if clinically meaningful results are reported. Herein, we present a timeline of all Accelerated Approvals granted to immune-checkpoint inhibitors to illustrate three ways in which the FDA has failed to fulfil their part in this social contract.
Source: Nature Reviews Clinical Oncology - Category: Cancer & Oncology Authors: Source Type: research