← Back to The Docket SEP 6 2026
APPROVED · 23 DAYS AGO
— Etcamah (camizestrant)
$AZN
for HR-positive, HER2-negative, locally advanced or metastatic breast cancer with ESR1 mutations
NDA
FDA grants accelerated approval to camizestrant (Etcamah) plus a CDK4/6 inhibitor for HR-positive, HER2-negative advanced breast cancer with ESR1 mutations.
About
HR-positive, HER2-negative advanced breast cancer is driven by estrogen signaling, which fuels tumor growth. Etcamah (camizestrant) is an oral drug that blocks the estrogen receptor, the protein that receives this growth signal. By directly targeting this receptor, even when it is mutated, the drug may help control cancer progression in patients who have developed resistance to other hormone therapies.
Pivotal trial
SERENA-4 Phase 3 active not recruiting NCT04711252 The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with...
Source: ClinicalTrials.gov