The UAE has made history as the first country in the world to approve Etcamah, AstraZeneca's oral targeted therapy for patients with advanced or metastatic breast cancer who develop an ESR1 gene mutation during hormone therapy.
The Emirates Drug Establishment (EDE) granted the approval following a comprehensive scientific and regulatory review covering the medicine's quality, safety, efficacy and supporting clinical data. The decision was anchored in findings from the Phase III SERENA-6 trial, which showed statistically and clinically significant improvements in progression-free survival among eligible patients.
Etcamah, based on the active ingredient camizestrant, is a next-generation oral selective estrogen receptor degrader used in combination with a CDK4/6 inhibitor. It works by blocking and degrading estrogen receptors in breast cancer cells, which can drive tumour growth and spread.
EDE Director-General Dr Fatima Al Kaabi said the approval reflects the efficiency of the UAE's regulatory framework in evaluating pharmaceutical innovations through rigorous scientific standards.
"This milestone will further strengthen the UAE's commitment to building a flexible pharmaceutical ecosystem capable of anticipating global scientific developments,"
she said.
Sameh El Fangary, Gulf Country President at AstraZeneca, called the approval an important step toward expanding treatment options for breast cancer patients in the region, adding that the company looks forward to strengthening collaboration with UAE partners to improve outcomes for eligible patients.
The EDE also highlighted the broader role of early detection, treatment adherence and regular medical follow-up in improving patient recovery outcomes.
The approval positions the UAE as a leading destination for pharmaceutical innovation and signals its continued commitment to giving patients faster access to cutting-edge therapies.
News Source: Emirates News Agency
