Joanna Sadowska, Biopharma Account Specialist at Nanolive SA, shared on LinkedIn:
“Big News – FDA approves AstraZeneca’s oral SERD combination therapy after cutting breast cancer progression risk by 56%.
Few days ago, the FDA approved AstraZeneca’s Etcamah (a Selective Estrogen Receptor Degrader) in combination with a CDK4/6 inhibitor as a 1st line treatment for certain patients with HR-positive, HER2-negative advanced breast cancer.
The approval was based on Phase 3 SERENA-6 results, and this trial did something different.
The Phase 3 trial monitored patients for ESR1 mutations using circulating tumor DNA from a blood test.
This is important because around 30% of patients with endocrine-sensitive HR-positive disease develop ESR1 mutations during first-line treatment before disease progression.
Once the mutation was detected, treatment was changed before there were clinical or radiological signs of disease progression which reduced the risk of disease progression or death by 56%.
This is a big shift because it tackles molecular resistance before we can see the disease progressing clinically or on imaging.
This is AstraZeneca’s 10th FDA approval in 2026 – and fourth in breast cancer alone.”
You can read also:
AstraZeneca Completes Zegfrovy Deal for EGFR Exon 20 Insertion NSCLC
