AstraZeneca's Camizestrant Recommended for EU Breast Cancer Approval
AstraZeneca's camizestrant, in combination with a CDK4/6 inhibitor, has been recommended for approval in the European Union by the CHMP for the treatment of adult patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer with an emergent ESR1 mutation. This positive opinion is based on pivotal SERENA-6 Phase III trial results, which showed the combination reduced the risk of disease progression or death by 56% and demonstrated a median progression-free survival of 16.0 months versus 9.2 months. If approved, camizestrant could reshape 1st-line treatment for patients in Europe with this type of advanced breast cancer, building on existing approvals in the UAE and Saudi Arabia.
Key Highlights
- AstraZeneca's camizestrant recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer.
- Recommendation based on SERENA-6 Phase III trial results.
- Combination reduced the risk of disease progression or death by 56% (HR 0.44).
- Median progression-free survival (PFS) was 16.0 months versus 9.2 months.
- PFS2 benefit of 25.7 months versus 19.1 months demonstrated.
- Camizestrant combination is approved in the United Arab Emirates and Saudi Arabia.
- Regulatory applications are currently under review in the US, Japan, and other countries.
Price Impact
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