The FDA has delayed its decision on AstraZeneca’s oral SERD camizestrant after an advisory committee vote went against approval for a first-line setting in a subset of advanced breast cancer patients. The company said additional time is needed to review analyses requested by the agency, extending the timeline beyond the original PDUFA window. The review focuses on camizestrant combined with AstraZeneca’s proposed regimen (including an AKT inhibitor Truqap in the broader application context) and centers on whether the pivotal SERENA-6 trial design and available evidence support approval. FDA advisers previously questioned trial conduct, survival data, and quality-of-life findings. Europe is moving in parallel: the EMA’s CHMP backed camizestrant for an ER+/HER2- ESR1-mutant advanced or metastatic breast cancer indication in combination with a CDK4/6 inhibitor, contingent on European Commission approval. The juxtaposition underscores the split between regulators as companies prepare for market access and payer discussions in major geographies.