Accelerated Approval Of Anticancer Drugs: Lessons Learned From The Example Of Olaratumab

The accelerated approval pathway allows anticancer drugs to be approved based on surrogate end points. Following initial approval, postapproval confirmatory studies are required to evaluate the actual clinical benefit. In the setting of accelerated approval, the exposure-response (E-R) relationship could be supportive. However, a positive E-R relationship should not be misinterpreted, especially in cases of monoclonal antibodies which present complex pharmacokinetic characteristics.