A breast cancer drug that cuts the risk of the disease by more than half during trials was approved for use in the UAE.
The Emirates Drug Establishment (EDE) has become one of the first regulators to give the go-ahead to AstraZeneca's Etcamah, which is aimed at patients who have particular types of advanced breast cancer, which can lead to the development of a genetic mutation.
The drug, which is actually called Camizestrant but sold under the brand name Etcamah, is said to delay the need for patients to undergo chemotherapy by preventing tumours from becoming larger.
Etcamah is deemed suitable for patients who, as a result of their breast cancer treatment, have developed mutations in a gene called ESR1, which causes the body to produce a substance that assists the hormone oestrogen in some of its activities. During trials it reduced the risk of death from the disease by 56 per cent, according to AstraZeneca.
“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,” said Fatima Al Kaabi, EDE's director general, who added that the approval demonstrated the efficiency of the UAE’s regulatory framework for drugs.
“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.”
'Milestone'
According to the EDE, Etcamah has been approved after “a comprehensive scientific and regulatory assessment” by the organisation that considered both how safe and effective it is.
Breast cancer cases around the world are forecast to rise by about 50 per cent in a generation, with Middle East countries likely to be among the most affected, a study released earlier this year claimed.
Breast cancer remains the most common kind among women worldwide and leading cause of premature death, with annual new cases expected to rise from 2.3 million in 2023 to more than 3.5 million by 2050.
The death toll in that period is expected to increase from 764,000 to nearly 1.4 million, according to the latest analysis from the Global Burden of Disease Study Breast Cancer Collaborators, published in The Lancet Oncology.
According to reports from patients who took Etcamah in trials, the drug improves quality of life and slows the worsening of symptoms.
The drug's approval expands the treatment options for breast cancer, according to Sameh El Fangary, Gulf country president at AstraZeneca. It also, he said in a statement, indicates confidence regarding the evidence of how effective the drug is.
“We look forward to strengthening collaboration with partners across the UAE to help improve treatment outcomes for eligible patients,” he said.
During the trials, the time period for how long it took for cancer to worsen was significantly longer, 16 months, for those who took Etcamah, compared to the nine months for those who did not take it.
The longer it takes for a cancer to worsen will significantly reduce the need for other treatments, including chemotherapy, which often has unpleasant side effects.
Trials of the drug were co-led by scientists at the Institut Curie, Paris, The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust in the UK, and their results were presented at a conference in Chicago almost exactly a year ago.
The UAE is among the first nations worldwide to give the go-ahead for the use of Etcamah.
Last month, the Saudi Food and Drug Authority approved the registration of Etcamah for use with the same category of patients for which it has been authorised in the UAE.
Also last month, a European Medicines Agency committee recommended approval for camizestrant in the European Union.
However, at the end of April a committee of the US Food and Drug Administration that analysed the same trial data voted not to approve the drug.
According to reports by specialist pharmaceutical media, there were reservations about, among other things, how the trial was designed and its way of measuring the length of time during which the disease did not worsen.
