FDA approves AstraZeneca's oral SERD Etcamah for HR+/HER2-negative advanced breast cancer

FDA granted approval to AstraZeneca's camizestrant, marketed as Etcamah, an oral selective estrogen receptor degrader (SERD) for a specific subset of advanced breast cancer patients.

The indication is for HR+/HER2-negative tumors with ESR1 mutations after prior aromatase inhibitor and CDK4/6 inhibitor therapy, to be used together with a CDK4/6 inhibitor such as Verzenio, Ibrance or Kisqali.

The approval comes despite a May advisory committee vote of 6-3 against the drug, where panelists raised concerns about the design of the pivotal SERENA-6 trial, which switched patients early based on mutation testing rather than disease progression.

Analysts at Leerink describe the market opportunity as modest for now, but anticipate that upcoming late-stage readout data could expand the drug's potential significantly.