AstraZeneca’s Etcamah-CDK4/6 combo wins EU approval for 1st-line advanced ER-positive breast cancer

• AstraZeneca won EU clearance for Etcamah with a CDK4/6 inhibitor in 1st-line ER-positive, HER2-negative advanced breast cancer with emergent ESR1 mutation.
• SERENA-6 interim data showed a 56% lower risk of progression or death vs aromatase inhibitor regimen; median PFS 16 months vs 9.2.
• US FDA extended the PDUFA date to review updated SERENA-6 results; applications remain under review in other markets.

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