FDA grants accelerated approval to AstraZeneca’s Etcamah, enabling ctDNA-guided therapy for HR-positive breast cancer

The FDA issued an accelerated approval for AstraZeneca’s oral selective estrogen receptor degrader camizestrant, to be sold as Etcamah, marking a rare departure from its advisory committee’s recommendation.

Etcamah is approved for use together with a CDK4/6 inhibitor in patients with hormone-receptor-positive, HER2-negative breast cancer, but only when an ESR1 mutation is detected in circulating tumor DNA during first-line aromatase-inhibitor therapy.

The decision is based on the phase 3 Serena-6 trial, which showed that patients who switched to the Etcamah-CDK4/6 regimen after an emergent ESR1 mutation had a substantial improvement in outcomes compared with those who remained on their original therapy.

Analysts said the approval is significant not for the drug itself but because it validates a ctDNA-guided treatment approach before radiographic progression, potentially shaping future oncology drug development.