What did the FDA’s September breast cancer approval actually change?

The FDA announcement describes an accelerated approval, a pathway that can make a treatment available based on an earlier measure reasonably likely to predict benefit while confirmatory studies continue. The practical change is a new option for the specific patients and tumor characteristics named in the label—not a universal breast-cancer cure. Patients need pathology testing and an oncology review to know whether the approved indication fits, and the ongoing trial still matters for confirming benefit.