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# AstraZeneca Wins Accelerated Approval for Breast Cancer Drug
- URL: https://www.fdaweb.com/astrazeneca-wins-accelerated-approval-for-breast-cancer-drug/
- Published: 2026-09-04T12:00:00.000Z
- Updated: 2026-09-14T12:05:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161738

FDA has granted AstraZenenca an accelerated approval for Etcamah (camizestrant), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. The approval applies to patients who have an estrogen receptor-1 (*ESR1)* mutation. The agency also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with the mutation.

Approval was supported by data from the SERENA-6 (NCT04964934), a randomized, double-blind, placebo-controlled, multicenter trial involving 315 patients, according to FDA. “The primary efficacy outcome measure was investigator-assessed progression-free survival (PFS) per RECIST v1.1,” it says. “An additional efficacy outcome measure included overall survival (OS). Median PFS was 16 months (95% CI: 12.7, 18.2) in the camizestrant and CDK4/6 inhibitor arm and 9.2 months (95% CI: 7.2, 9.5) in the AI and CDK4/6 inhibitor arm (Hazard ratio 0.44 \[95% CI: 0.31, 0.60\]; p-value < 0.00001). At the time of the PFS analysis, OS data were not mature.”

The approved labeling includes a Boxed Warning for the risk of arrhythmia due to QTc interval prolongation when concomitantly used with QTc interval-prolonging drugs, as well as warnings and precautions for bradycardia and embryo-fetal toxicity.