AstraZeneca's breast cancer drug granted accelerated approval in the US.
Drugmaker AstraZeneca said on Monday that its breast cancer drug Etcamah (camizestrant), used alongside a CDK4/6 inhibitor, has been granted accelerated approval in the US for patients with a common form of advanced breast cancer who show signs of developing resistance to standard hormone therapy.
AstraZeneca
07 September 2026 08:45:05
Source: Sharecast
AstraZeneca said the decision was based on an FDA‑authorised blood test that detects emerging ESR1 mutations, which signal that current treatment was becoming less effective and follows results from its Phase III SERENA‑6 trial.
In an interim analysis, the Etcamah combination cut the risk of disease progression or death by 56% compared with continuing aromatase‑inhibitor therapy, extending median progression‑free survival to 16 months from 9.2 months. A later planned analysis showed a meaningful improvement in time to second progression, while overall‑survival data continued to trend in favour of the regimen.
The FTSE 100-listed firm said the safety profile of Etcamah used with palbociclib, ribociclib or abemaciclib was in line with expectations, with no new concerns identified and low discontinuation rates.
AstraZeneca added that alongside the drug approval, the FDA also cleared a companion diagnostic designed to detect ESR1 mutations through circulating tumour DNA.
As of 0845 BST, AstraZeneca shares were up 0.70% at 12,090p.
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