AstraZeneca says FDA approves Etcamah-CDK4/6 combo for first-line advanced HR-positive breast cancer

• FDA granted accelerated clearance for AstraZeneca’s Etcamah with a CDK4/6 inhibitor in first-line advanced HR-positive, HER2-negative breast cancer.
• Use targets patients who develop an emergent ESR1 mutation during aromatase inhibitor treatment, confirmed via an FDA-authorized test.
• SERENA-6 data showed a 56% lower risk of progression or death versus standard care; median PFS 16 months versus 9.2.

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