Two separate FDA oncology advisory panel votes left AstraZeneca’s camizestrant strategy facing setbacks. On one track, experts voted 6–3 against a “new paradigm” in an AstraZeneca trial for the oral SERD camizestrant, citing a lack of clinically meaningful benefit. On a second track, the panel voted 6–3 that evidence did not support switching patients based on ESR1 mutations detected in ctDNA, rather than waiting for radiographic progression. The divide reflects how strongly the panel weighted outcome relevance over biomarker-driven changes in treatment timing. For developers, the deliberations underscore that FDA committees are signaling heightened skepticism around trial designs that alter the treatment decision point, even when the molecular rationale is present.
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