Breast cancer ESR1 mutation oral SERD FDA approval with CDK4/6 inhibitor combination treatment
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AstraZeneca Receives FDA Approval for Camizestrant in ESR1-Mutated Breast Cancer

AstraZeneca announces FDA approval of camizestrant plus CDK4/6 inhibitor for ESR1-mutated ER+/HER2- advanced breast cancer after prior endocrine therapy.

AstraZeneca today announced that the FDA has approved camizestrant in combination with CDK4/6 inhibitors for the treatment of adults with ESR1-mutated ER-positive, HER2-negative locally advanced or metastatic breast cancer who have received prior endocrine therapy. In the Phase 3 SERENA-6 trial, camizestrant plus CDK4/6 inhibitor demonstrated a statistically significant improvement in progression-free survival versus aromatase inhibitor plus CDK4/6 inhibitor. Camizestrant is a next-generation oral SERD that degrades the estrogen receptor.

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