Prime Highlights-
- The UAE became the first country to approve AstraZeneca’s Etcamah for ESR1-mutated advanced breast cancer.
- The approval was supported by Phase III SERENA-6 trial results showing improved progression-free survival.
Key Facts-
- AstraZeneca is a global pharmaceutical company with a strong focus on cancer treatments.
- Etcamah targets ESR1 mutations that can develop during hormone therapy in breast cancer patients.
Background-
The UAE has become the first country to approve AstraZeneca’s Etcamah for patients with advanced or metastatic breast cancer carrying an ESR1 gene mutation, a resistance that develops in some patients during hormone therapy.
Etcamah targets the problem at its source. It blocks and breaks down estrogen receptors in breast cancer cells that fuel tumor growth, and is given alongside a CDK4/6 inhibitor. Its active ingredient, camizestrant, is a next-generation oral selective estrogen receptor degrader.
The Emirates Drug Establishment cleared the drug following a full review of its quality, safety, and efficacy. Regulators based their decision on Phase III SERENA-6 trial data, which recorded significant gains in progression-free survival among patients who developed the ESR1 mutation while already on endocrine therapy.
Emirates Drug Establishment Director-General Fatima Al Kaabi said the approval demonstrates how the UAE’s regulatory system can move quickly without compromising scientific standards, and that the country is positioned to stay ahead of global developments in the pharmaceutical sector.
AstraZeneca Gulf Country President Sameh El Fangary called the clearance a meaningful step forward for breast cancer patients and said the company looks forward to working with partners across the UAE to improve outcomes for those who qualify for the treatment.
Breast cancer is among the most frequently diagnosed cancers in women worldwide. The Emirates Drug Establishment used the occasion to remind patients of the role early detection and regular medical follow-up play in improving recovery outcomes.
