The FDA Etcamah approval expands treatment options for certain adults with advanced breast cancer and includes a newly authorized liquid-biopsy companion diagnostic.
The Food and Drug Administration granted accelerated approval to AstraZeneca’s (Nasdaq: AZN) camizestrant, marketed as Etcamah, in combination with a CDK4/6 inhibitor. The agency described the indication and supporting evidence in its official approval notice.
The treatment is intended for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer when an ESR1 mutation is detected during treatment with an aromatase inhibitor and a CDK4/6 inhibitor.
FDA Etcamah Approval Uses Guardant360 for Earlier Mutation Detection
The FDA also approved Guardant Health’s (Nasdaq: GH) Guardant360 CDx assay to identify eligible patients through circulating tumor DNA. The test is designed to detect emerging ESR1 resistance mutations before radiographic disease progression.
In the 315-patient SERENA-6 trial, median progression-free survival was 16 months for patients switched to camizestrant plus a CDK4/6 inhibitor, compared with 9.2 months for those who continued an aromatase inhibitor with a CDK4/6 inhibitor. Overall-survival data were not mature.
The prescribing information carries warnings including the risk of arrhythmia from QTc prolongation in certain combinations. Because the authorization uses the accelerated pathway, continued approval may depend on confirmation and further description of clinical benefit in additional trials.
