LONDON (dpa-AFX) - AstraZeneca (AZN, AZN.L, ZEG.DE, AZN.ST) said its Etcamah or camizestrant in combination with a cyclin-dependent kinase 4/6 inhibitor - abemaciclib, palbociclib or ribociclib - has been approved in the US for the treatment of adult patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on a FDA-authorised test. The accelerated approval was based on results from the pivotal SERENA-6 Phase III trial. The FDA also approved a companion diagnostic test to detect emerging ESR1 resistance mutations in the circulating tumour DNA of patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
Etcamah is approved in more than 30 countries across the globe, including in the EU, Japan, Canada, the UK and several other countries.
At last close on LSE, AstraZeneca shares were trading at 12,146.00 pence.
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