AstraZeneca's Etcamah Approved in EU for ER+ Breast Cancer
AstraZeneca's Etcamah, in combination with a CDK4/6 inhibitor, has received EU approval for the 1st-line treatment of adult patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. This approval specifically targets patients with an emergent ESR1 tumour mutation who have not experienced disease progression during initial endocrine therapy. The decision is based on the pivotal SERENA-6 Phase III trial, which demonstrated a significant 56% reduction in the risk of disease progression or death. Etcamah is positioned as the first and only next-generation oral SERD and complete ER antagonist approved in this setting, marking it as the 11th new medicine from AstraZeneca expected to launch by 2030.
Key Highlights
- EU approval granted for AstraZeneca's Etcamah in combination with CDK4/6 inhibitors.
- Indicated for 1st-line treatment of ER-positive, HER2-negative advanced breast cancer.
- Targets patients with emergent ESR1 tumour mutation without disease progression during 1st-line endocrine therapy.
- SERENA-6 trial showed 56% reduction in disease progression or death risk (HR 0.44).
- Median progression-free survival (PFS) was 16.0 months vs. 9.2 months for standard-of-care.
- Etcamah is the 11th new AstraZeneca medicine of 20 expected to launch by 2030.
- Also approved in Japan, UAE, and Saudi Arabia; under review in the US.
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