The Emirates Drug Establishment (EDE) has approved Eticamah, a new oral targeted therapy developed by AstraZeneca for patients with advanced or metastatic breast cancer whose tumours develop an ESR1 gene mutation during endocrine therapy.
With the approval, the UAE becomes the first country in the world to make the treatment available, reflecting its commitment to accelerating access to innovative medicines, strengthening the healthcare system and expanding advanced treatment options for patients.
The therapy is used in combination with a CDK4/6 inhibitor and is based on the active ingredient camizestrant, a next-generation oral selective oestrogen receptor degrader (SERD) and complete oestrogen receptor antagonist. It works by blocking and degrading oestrogen receptors in breast cancer cells, helping to inhibit tumour growth and disease progression.
Strengthening the Pharmaceutical System
Dr Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, said the approval reflects the organisation’s ability to rapidly evaluate and adopt innovative medicines through rigorous scientific and regulatory processes.
She added that the decision supports the readiness of the UAE’s pharmaceutical system and enhances its capacity to provide patients with advanced treatment options.
Dr Al Kaabi said the approval is part of the country’s broader strategy to build a flexible pharmaceutical ecosystem capable of keeping pace with global scientific advances while balancing rapid access to new therapies with the highest standards of safety, quality and effectiveness. She noted that this approach further strengthens the UAE’s position as a trusted regional hub for pharmaceutical innovation.
Backed by Clinical Evidence
Sameh El Fangary, President of AstraZeneca Gulf, described the availability of the treatment in the UAE as an important step in expanding therapeutic options for breast cancer patients and a reflection of confidence in the medicine’s scientific foundation.
He added that the company looks forward to strengthening collaboration with healthcare partners across the UAE to improve treatment outcomes for eligible patients.
The approval followed a comprehensive scientific and regulatory review by the Emirates Drug Establishment, which assessed the medicine’s quality, safety and efficacy, as well as supporting clinical data. The decision was based on findings from the Phase III SERENA-6 clinical trial, which demonstrated a statistically and clinically significant improvement in progression-free survival among patients whose ESR1 mutation emerged during endocrine therapy.
Breast cancer remains the most common cancer among women worldwide, underscoring the importance of expanding access to innovative treatments that improve clinical outcomes and enhance patients’ quality of life.
