Sunday 20 June 2021
The UAE's Ministry of Health and Prevention (MoHAP) has 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 120 mg 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.
The UAE is the second country in the world to approve the drug, the first after the United States. This 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.