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