UAE first country in world to approve new oral breast cancer drug for hormone-resistant cases

Dubai: The UAE has become the first country in the world to approve a new oral treatment for a specific type of advanced or metastatic breast cancer, offering renewed hope to patients whose tumours have stopped responding to hormone therapy.

The Emirates Drug Establishment (EDE) has approved AstraZeneca's Etcamah®, an oral targeted therapy for patients with advanced or metastatic breast cancer who have developed an ESR1 gene mutation. It is a genetic change that can occur while a patient is already on endocrine (hormone) therapy, effectively making that treatment less effective.

According to EDE, Etcamah® works by blocking and degrading estrogen receptors in breast cancer cells. In certain tumours, these receptors act like a fuel switch, driving cancer growth and spread. By shutting down and dismantling those receptors, the drug cuts off that signal. It is taken orally and used in combination with a CDK4/6 inhibitor, a class of drugs already widely used in breast cancer treatment.

The active ingredient, camizestrant, is a next-generation oral selective estrogen receptor degrader (ngSERD) and full estrogen receptor antagonist. It is the latest evolution in a line of treatments designed to target hormone-driven breast cancers.

With this approval, the UAE becomes the first country in the world to make this treatment option available, as part of its commitment to accelerating access to pharmaceutical innovation, advancing the quality of the healthcare system, and expanding access to advanced treatment options for patients.

Dr Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, said that the decision to approve Etcamah® reflects the efficiency of the UAE's regulatory and operational framework in evaluating and adopting pharmaceutical innovations through rigorous scientific standards.

Al Kaabi noted that this approach supports the readiness of the national pharmaceutical ecosystem and strengthens its ability to provide advanced treatment options for patients.

She added: "This milestone will further strengthen the UAE's commitment to building a flexible pharmaceutical ecosystem capable of anticipating global scientific developments and keeping pace with the rapid evolution of the pharmaceutical sector. Through advanced assessment tools that balance accelerated access with the highest standards of safety and quality, we will continue to reinforce the UAE's position as a trusted reference point for pharmaceutical innovation."

The approval was granted following a comprehensive scientific and regulatory assessment conducted by the Emirates Drug Establishment, including a review of the medicine's quality, safety and efficacy, as well as an analysis of the clinical data supporting its use.

The decision was based on findings from the Phase III SERENA-6 trial, which demonstrated statistically and clinically significant improvements in progression-free survival among patients who developed the mutation while receiving endocrine therapy.

Sameh El Fangary, Gulf Country President at AstraZeneca, said that making this treatment available in the UAE is yet another important step towards expanding treatment options for breast cancer and reflects confidence in the scientific evidence underpinning the medicine.

El Fangary added: "We look forward to strengthening collaboration with partners across the UAE to help improve treatment outcomes for eligible patients."

Breast cancer is one of the most common cancers among women, demonstrating the significance of expanding access to innovative treatment options that contribute to improved clinical outcomes and enhanced quality of life for patients.

The Emirates Drug Establishment emphasised the importance of early detection of breast cancer, adherence to prescribed treatment plans, and regular follow-up with healthcare professionals, as these play a vital role in improving treatment response and enhancing recovery outcomes.