UAE greenlights new drug to treat patients with lung cancer
- Last updated: June 20, 2021 | 14:19
Mariecar Jara-Puyod, Senior Reporter
Adult Non-Small Cell Lung Cancer (NSCLC) patients in the UAE, specifically those suffering from KRAS G12C-locally mutated and advanced or metastatic NSCLC and who have received at least one form of therapy, now have better chances of improving or overcoming their condition.
The good news is so as the UAE, with world class healthcare, as among the pillars of its National Agenda 2021, becomes the second country in the world, after the USA to allow the distribution of an oral anti-cancer medication known as Sotorasib, classified as an inhibitor.
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NSCLC, according to the World Health Organisation, is generally regarded a disease of the elderly (but as of 2014), had been diagnosed before the age of 65 years old (while) surgery and adjuvant chemotherapy are important contributors to cure for early stages. It accounts for majority of lung cancer cases worldwide.
Ministry of Health and Prevention (MoHaP) undersecretary/Emirates Health Services-Board of Directors head Dr. Mohammed Salim Al Olama on Saturday said the decision for the approval for the entry, distribution and use of the 120-milligramme film-coated Sotorasib tablets, under the brand name Lumakras, is in line with the national leadership thrust to prioritise patient health.
The NSCLC therapeutic drug was researched and developed by the American multinational biopharmaceutical firm Amgen, headquartered in California (USA). Its MoHaP medicine registration was accomplished through the Fast Track/Accelerate Process System innovative mechanism.
The Pharma Boardroom portal states the MoHaP Fast Track/Accelerate Process System is carried out by the Drug Registration Committee that evaluates an application for a new drug within 15 working days of submission and makes the decision to approve or reject the application within 10 working days from the date of application.
Meanwhile, according to the Baker McKenzie website, the UAE Law Number 8 of 2019 on Medical Products, Pharmacy Professions and Pharmaceutical Establishments, is in part about, among others, the product registration and status of marketing authorisation holder/applicant; and import, export, distribution and warehousing of both human and veterinary medicines, medical devices and health-related consumer goods.
MoHaP-Public Health Policy and Licensing assistant undersecretary Dr. Amin Hussein Al Amiri said the approval of innovative and new medicines that which have at least one newly discovered substance to treat a specific ailment is a well-thought out strategy in close collaboration with homegrown as well as multinational pharmaceutical companies. It is employed in order to achieve the UAE National Agenda 2021. In the case of the Lumakras approval, this would help mitigate the burden on the healthcare system, reduce the number of critical cases, and provide new therapeutic options that contribute to improving the health of patients with lung cancer and reducing (the probability of overseas medical treatments).
According to the Amgen portal, the US Food and Drug Administration granted the green light and approved Lumakras for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC on May 28, 2021. The FDA seal was considered a breakthrough since KRASG12C is one of the most prevalent biomarkers (a naturally occurring molecule, gene or characteristic by which a particular pathological or physiological process or disease is identified) in (NSCLC). It brings hope to the many patients who carry this mutation and is a significant moment for the lung cancer community who need more innovative treatment options.
Amgen (Gulf Cooperation Council) country manager Dr. Ahmed Mostafa said: We are very grateful to the (MoHaP) for their painstaking efforts, approach, and vision in ensuring the immediate availability of the new and innovative medicines in the UAE.
The Lumakras approval by MoHaP was dated June 14, 2021. It comes after the government agency sealed the approval of the Sotrovimab-VIR 7831 emergency drug against the Novel Coronavirus on May 27, 2021.
Two online lung cancer discussions were recently held in the UAE. First was the “2nd GCC Multidisciplinary Lung Cancer Forum attended by international healthcare professionals who called for increased lung cancer screenings for high-risk patients to reduce the number of disease-related deaths in the Gulf including the UAE. Forum chairperson/International Cincinnati Advisors International Programme director/Alfaisal University (Saudi Arabia) Oncology adjunct professor Dr. AbdulRahman Jazieh said: Lung cancer is one of the top cancer killers in the world causing a lot of suffering and mortality in our region, making it crucial for patients to receive optimum care.
Emirates Oncology Society president/Burjeel Cancer Institute director Dr. Humaid Al Shamsi said that while screenings are well-embedded within the healthcare system, still, only a few take advantage. In the UAE, whilst our government is introducing tighter regulations aimed at encouraging people to quit smoking, research indicates that lung cancer is actually on the rise amongst young people.
The second lung cancer online discussion was hosted by the Skyline University College in Sharjah wherein freelance registered clinical dietician Varsha Menon emphasised on the value of imbibing the habit of balanced diet and the importance of the consumption of lots of fruits and vegetables.
NMC Royal & Specialty Hospital (Abu Dhabi) Oncology Department head Dr. Mohanad Diab said that since 2008 and across all types of cancer, over 800 anti-cancer medications have been researched and developed, causing the disease to be curable “and several were cured.†He added that lung cancer which would be treated accordingly to its stage of diagnosis is the second most prevalent in the UAE and the commonest in Qatar, Kuwait and Bahrain.