FDA drug application records confirm Etcamah approval details, dosage form

FDA drug application records for NDA220359 confirm the details of the accelerated approval announced by the agency for Etcamah (camizestrant), AstraZeneca's new breast cancer treatment. The filing shows Etcamah as a film-coated tablet with 75 mg of camizestrant as the active ingredient, submitted by AstraZeneca Pharmaceuticals, LP, with a submission status date of 2026-09-04.¹

The underlying approval, announced by the FDA on September 4, 2026, covers Etcamah in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK 4/6 inhibitor therapy, based on an FDA-authorized test.²

According to the FDA, fewer than 5 percent of patients have this tumor mutation at diagnosis of HR-positive metastatic breast cancer, while nearly 40 percent develop it after disease progression on an aromatase inhibitor.²

The approval relied on a trial in which estimated median progression-free survival was 16 months in the Etcamah and CDK4/6 inhibitor arm, compared with 9.2 months in the aromatase inhibitor and CDK4/6 inhibitor arm.² The FDA said accelerated approval was granted based on how long patients lived without their disease worsening, measured from the point when the resistance mutation was first detected in the blood.² Confirmatory studies are still required.

The FDA also authorized the Guardant360 CDx assay as a companion diagnostic, and the label carries a boxed warning for irregular heart rhythm risk when combined with certain medications. An FDA advisory committee reviewed the application on April 30, 2026.²