The FDA delayed its decision on AstraZeneca’s oral SERD camizestrant after an advisory committee vote turned down the drug for certain advanced breast cancer indications. The company said the agency requested additional analyses and pushed the action date back, without specifying the new target date. The advisory panel previously raised concerns around SERENA-6 design, lack of survival data, and unclear quality-of-life benefit. AstraZeneca is seeking approval in combination strategies that target ESR1-mutant, HER2-negative, HR-positive disease. The delay extends uncertainty for the oral SERD development pathway in breast cancer, particularly because European regulators have already recommended approval for the product.