FDA approval standards for anticancer agents - lessons from two recent approvals in breast cancer

Two recent drug approvals for metastatic breast cancer highlight that the evidence standards required to support FDA approval seem to be decreasing. These two drugs not only failed to improve overall survival, but their effects on progression-free survival were also astonishingly low; in one case, the treatment delayed progression by only 3 days.

Automated summary

The recent approvals of two drugs for metastatic breast cancer suggest that the evidence standards for FDA approval may be decreasing. These drugs not only failed to improve overall survival but also had minimal effects on progression-free survival, delaying progression by only 3 days in one case.