← All approvals · Cancer · 2026
Etcamah (camizestrant)
The FDA approved Etcamah (camizestrant) on September 4, 2026 to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy.
- Brand name
- Etcamah
- Generic name
- camizestrant
- FDA approval date
- September 4, 2026
- Approved use (FDA wording)
- To treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy
- Company
- Astrazeneca
- Application
- NDA220359
- Dosage form / route
- TABLET · ORAL
- Boxed warning on label
- Yes (see the FDA label)
- Category on this site
- Cancer
Indications and usage, from the FDA label
ETCAMAH in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test [see Dosage and Administration ( 2.1 )] . This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of…