(RTTNews) - AstraZeneca (AZN) on Thursday announced that the company's Etcamah (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) has been approved in the European Union or EU for the treatment of adult patients for an advanced breast cancer indication.

Specifically, the approval is for estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of an ESR1 mutation and without disease progression during 1st-line endocrine therapy in combination with a CDK4/6 inhibitor.

Breast cancer is the most commonly diagnosed cancer worldwide and one of the leading causes of cancer-related deaths worldwide. According to company estimates, more than two million patients were diagnosed with breast cancer in 2024, with more than 690,000 deaths globally.

The approval follows the positive opinion of the Committee for Medicinal Products for Human Use and was backed by positive results from the pivotal SERENA-6 Phase III trial.

Etcamah (camizestrant) is an oral selective estrogen receptor degrader (SERD) and complete ER antagonist, administered orally once daily. The recommended dose of Etcamah in combination with a CDK4/6 inhibitor is 75mg.

SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation.

According to the company, in the interim analyses, the Etcamah combination reduced the risk of disease progression or death by 56% compared to standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor.

Median progression-free survival (PFS) was 16.0 months compared to 9.2 months in standard-of-care treatment.

The safety profile of Etcamah in combination with palbociclib, ribociclib, or abemaciclib in the SERENA-6 trial was consistent with the known safety profile of each medicine, the company said.

AstraZeneca focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

AZN has traded between $142.98 and $212.71 over the last year. The stock closed Wednesday's trade at $169.73, down 0.23%.

AZN is currently down 0.90% at $168.25 in the pre-market.

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