The FDA granted accelerated approval to AstraZeneca’s oral selective estrogen receptor degrader, camizestrant (Etcamah), for certain patients with HR+/HER2− advanced breast cancer with detected ESR1 mutations. The decision came after an independent advisory committee voted against the drug earlier this year. The approval relies on AstraZeneca’s phase 3 SERENA-6 data, including a progression-free survival benefit and a clinically significant reduction in the risk of death or disease progression in the approved patient subset. The agency paired the approval with Guardant Health’s Guardant360 companion diagnostic to identify ESR1-mutated patients. Analysts expect the approval to create a measurable, if “modest,” addressable market and set up further readouts for overall survival that could clarify the durability of benefit in real-world treatment sequencing.