Accelerated drug approvals in oncology: Pros and cons

The inevitable surge of the accelerated approval process, especially for oncology drugs, has been a success story. However, the use of surrogate end-points and its validation has been debatable over the years. Over the years, US Food and Drug Administration has been rigorously working for the validation of these end-points to capture the real clinical benefit and appropriateness of clinical study designs. However, the high cost imposed by the manufacturer attributed to the faster drug access can be prohibitive and well undermine the whole process. We discuss issues that must be addressed and solved accordingly for managed care in oncology.