emirates7 - The Emirates Drug Establishment (EDE) has approved AstraZeneca's Etcamah, an oral targeted therapy for a subset of patients with advanced or metastatic breast cancer who have developed an ESR1 gene mutation detected during endocrine (hormone) therapy.
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.
Etcamah is used in combination with a CDK4/6 inhibitor and is based on the active ingredient camizestrant, a next-generation oral selective estrogen receptor degrader (ngSERD) and full estrogen receptor antagonist. The therapy works by blocking and degrading estrogen receptors in breast cancer cells, which can contribute to tumour growth and spread.
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.”
Meanwhile, 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.”
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.
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.
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.
Etcamah is used in combination with a CDK4/6 inhibitor and is based on the active ingredient camizestrant, a next-generation oral selective estrogen receptor degrader (ngSERD) and full estrogen receptor antagonist. The therapy works by blocking and degrading estrogen receptors in breast cancer cells, which can contribute to tumour growth and spread.
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.”
Meanwhile, 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.”
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.
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.
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