Two separate FDA advisory panel threads highlighted how evidence standards for oncology use cases are tightening. An ODAC discussion of AstraZeneca’s oral SERD camizestrant produced a near-split vote after the agency considered a trial strategy that switches patients based on circulating tumor DNA (ctDNA) ESR1 status rather than waiting for radiographic progression. In parallel, another FDA oncology advisory decision rejected a “new paradigm” for camizestrant use in AstraZeneca’s trial framework. The panel vote questioned whether the drug delivered a clinically meaningful benefit under the proposed context, raising near-term uncertainty for where the oral SERD can be positioned. Together, the outcomes show ODAC’s focus on both endpoints and trial design assumptions—particularly for ctDNA-guided treatment switching—which can determine how quickly sponsors reshape their commercial plans.