DUBAI: In a significant development for cancer care and precision medicine, the United Arab Emirates has become the first country in the world to approve a new oral treatment designed for patients with a specific form of advanced breast cancer that has developed resistance to hormone therapy.
The Emirates Drug Establishment (EDE) has granted approval to Etcamah® (camizestrant), a next-generation targeted therapy developed by AstraZeneca for patients with advanced or metastatic breast cancer who develop an ESR1 gene mutation while receiving endocrine treatment.
The approval marks an important milestone in the evolving landscape of breast cancer treatment, where researchers are increasingly focusing on genetic changes that enable tumors to evade standard therapies.
Addressing one of the biggest challenges in breast cancer treatment
Hormone receptor-positive breast cancer is among the most common forms of breast cancer worldwide. Many patients initially respond well to endocrine therapies that block estrogen-driven tumor growth. However, over time, some cancers develop genetic mutations that allow them to bypass these treatments and continue growing.
One of the most clinically significant of these changes is the ESR1 mutation, which can emerge during treatment and reduce the effectiveness of conventional hormone therapies.
For patients whose cancer acquires this mutation, treatment options have historically become more limited, increasing the risk of disease progression.
Etcamah has been developed specifically to address this challenge by targeting the biological mechanism that drives treatment resistance.
How the new drug works
The active ingredient in Etcamah, camizestrant, belongs to a new generation of medicines known as next-generation oral selective estrogen receptor degraders (ngSERDs).
Unlike traditional hormone therapies that primarily block estrogen signaling, camizestrant is designed to both block and degrade estrogen receptors present on breast cancer cells.
These receptors often act as molecular switches that fuel the growth and spread of hormone-driven tumors. By disabling and removing these receptors, the treatment aims to interrupt cancer-promoting signals and slow disease progression.
The therapy is administered orally and is intended for use alongside a CDK4/6 inhibitor, a class of targeted medicines that has become a cornerstone of modern breast cancer management.
Approval backed by Phase III clinical evidence
According to the Emirates Drug Establishment, approval was granted following a comprehensive scientific and regulatory review evaluating the medicine's safety, quality, efficacy, and supporting clinical evidence.
The decision was based largely on results from the Phase III SERENA-6 clinical trial, which investigated the treatment in patients whose tumors developed ESR1 mutations during endocrine therapy.
The study demonstrated statistically and clinically significant improvements in progression-free survival, meaning patients receiving the treatment experienced longer periods before their cancer worsened compared with standard treatment approaches.
The findings have attracted significant attention within the oncology community because they represent a potential strategy for intervening at the moment treatment resistance begins to emerge.
UAE positions itself at the forefront of pharmaceutical innovation
The approval also highlights the UAE's growing ambition to become a regional and global leader in healthcare innovation and advanced therapeutics.
Dr Fatima Al Kaabi, Director-General of the Emirates Drug Establishment, said the decision reflects the country's ability to rapidly evaluate and adopt promising medical innovations while maintaining rigorous scientific and regulatory standards.
According to Al Kaabi, the approval supports the development of a responsive pharmaceutical ecosystem capable of keeping pace with rapidly advancing medical science and expanding access to innovative therapies for patients.
She emphasized that the milestone reinforces the UAE's commitment to accelerating access to cutting-edge medicines while ensuring the highest standards of safety, quality, and effectiveness.
AstraZeneca highlights new option for eligible patients
Sameh El Fangary, Gulf Country President at AstraZeneca, described the approval as an important step toward expanding treatment options for breast cancer patients whose disease has become resistant to conventional hormone therapy.
He noted that making the medicine available in the UAE reflects growing confidence in the scientific evidence supporting the treatment and its potential role in improving outcomes for eligible patients.
AstraZeneca said it will continue working with healthcare partners and regulatory authorities to support access to innovative cancer therapies across the region.
Why this approval matters
Breast cancer remains the most frequently diagnosed cancer among women globally and continues to be a leading cause of cancer-related mortality.
While advances in screening, surgery, targeted therapy, and personalized medicine have improved survival rates, treatment resistance remains one of the greatest challenges in long-term disease management.
The ability to identify genetic mutations such as ESR1 and intervene with precision therapies represents a major shift toward more individualized cancer treatment strategies.
For patients living with advanced or metastatic disease, such innovations offer the possibility of extending disease control, preserving quality of life, and delaying progression.
Although the long-term impact of camizestrant will continue to be evaluated through ongoing research and real-world clinical use, the UAE's approval of Etcamah represents a notable step forward in the global effort to improve outcomes for patients facing hormone-resistant breast cancer.
Health experts continue to emphasize that early detection, regular screening, adherence to prescribed treatment plans, and ongoing follow-up with oncology specialists remain essential components of successful breast cancer management.
As precision oncology continues to reshape cancer care worldwide, the approval of Etcamah underscores how targeted therapies are increasingly being used to address the genetic mechanisms that drive treatment resistance and disease progression.
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