Astrazeneca's Camizestrant cleared in the EU, Enhertu and Datroway pick up fresh recommendations

(Sharecast News) - Drugmaker Astrazeneca said on Tuesday that its breast cancer treatment camizestrant has secured EU approval, while its Enhertu and Datroway drug candidates also received fresh regulatory recommendations in Europe and the US.

The European Commission cleared camizestrant for use in combination with a CDK4/6 inhibitor as a first‑line treatment for ER‑positive, HER2‑negative advanced breast cancer with an emergent ESR1 mutation, following a positive opinion from the EMA's Committee for Medicinal Products for Human Use.

The decision was based on the Phase III SERENA‑6 trial, in which the combination cut the risk of disease progression or death by 56% versus standard endocrine therapy, delivering a median progression‑free survival of 16 months compared with 9.2 months. A pre‑planned analysis also showed a statistically significant improvement in progression-free survival.

Astrazeneca also said the CHMP had separately recommended Enhertu, developed with Daiichi Sankyo, for approval in the EU as a monotherapy for previously treated HER2‑positive metastatic solid tumours. If approved, Enhertu would become the first HER2‑directed therapy to receive a tumour‑agnostic indication in Europe.

Over in the US, the Food and Drug Administration approved Datroway for first‑line treatment of metastatic triple‑negative breast cancer in patients who are not candidates for PD‑1/PD‑L1 inhibitors. The decision follows Priority Review and results from Astrazeneca's Phase III TROPION‑Breast02 trial, where Datroway became the first TROP2‑directed ADC to show an overall‑survival benefit in this setting, with median overall survival of roughly two years.

As of 0900 BST, Astrazeneca shares were up 0.99% at 14,054p.

Reporting by Iain Gilbert at Sharecast.com

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