UAE becomes world's second country to approve Amgen’s lung cancer drug ‘Lumakras’

The Ministry of Health and Prevention (MoHAP) has recently approved the registration and use of Amgen’s lung cancer drug Lumakras, following the approval of the US Food and Drug Administration (FDA).

This will provide lung cancer patients early access to this innovative drug to help speed up their treatment plan and improve the quality of their life.

The registration comes because of the application of MoHAP’s innovative mechanism for its accelerators to evaluate and approve the world’s breakthrough drugs following the Fast Track/Accelerate Process system.

LUMAKRAS is supplied as a film-coated tablet for oral use containing 120mg of Sotorasib. The drug is prescribed to adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one previous cancer therapy.

Dr Mohammed Salim Al Olama, MoHAP Under-Secretary and Head of Board of Directors of the Emirates Health Services (EHS), said that the ministry, under the guidance of the wise leadership, is keen to further consolidate the UAE’s position in the global pharmaceutical market.

Al Olama underlined that the flexible legislative environment has stimulated the global pharmaceutical companies to choose the country as a hub for marketing and promoting their new and innovative products, which gives solutions to patients in the country and region.

The approval of this innovative treatment in the second country in the world comes a week after the UAE approved the emergency use of a highly effective new treatment for COVID-19, becoming the first country in the world to register the drug following the FDA approval. This would help enhance the UAE’s competitive position in establishing quality and safety for therapeutic, healthcare, and pharmaceutical systems in line with the UAE Centennial vision, added Al Olama.

Dr Amin Hussein Al Amiri, the Assistant Under-Secretary of the Ministry of Health and Prevention’s Public Health Policy and Licences, pointed out that the ministry is keen to enhance its partnerships with global pharmaceutical companies and enhance the best treatment and healthcare for cancer patients.

Al Amiri noted that the approval of the innovative and new medicines runs according to a well-thought-out mechanism for drug evaluation and registration, expressing his pleasure with the outstanding outcomes of the national indicators of cancer disease in line with the UAE National Agenda.

Dr Amin commended the keenness of international pharmaceutical companies to provide the UAE with the innovative drug manufacturing files at the same time that they are presented to international bodies such as the FDA and the European Medicines Authority (EMEA) to obtain global accreditation, which includes a review of clinical and bioequivalence studies and stability.

Dr Ahmed Mostafa, country manager of Amgen in GCC, said, "We are extremely proud of the UAE's approval for Lumakras drug, making it the second country in the world after the USA that approves and licences the medicine.

WAM