Amgen has announced that its treatment for a mutation of a common type of lung cancer was granted conditional marketing authorization by the European Commission.
With the commission’s approval and subject to local reimbursement applications, clinicians in all European Union member countries, in addition to Norway, Iceland and Liechtenstein, will be able to provide the product, called Lumykras, to appropriate patients with non-small cell lung cancer.
The treatment is now approved in 35 countries following the grant.
Amgen Executive Vice President of Research and Development David Reese said in a statement that the approval “has the potential to transform treatment outcomes for people in the European Union living with this notoriously difficult-to-treat cancer.”
The chemical name of the product is Sotorasib. It is marketed as Lumykras in the European Union and Great Britain while in the United States and other countries it is marketed with a slightly different spelling, Lumakras.
Lumakras received accelerated approval from the U.S. Food and Drug Administration in May.
Non-small cell lung cancer accounts for approximately 84 percent of the 2.2 million new lung cancer diagnoses that are made globally each year according to the World Health Organization.
Marketing Authorization Applications for Sotorasib are under review in Israel, Singapore, Brazil and Australia. Further applications have been submitted in Mexico, Colombia, Argentina, Japan, South Korea, Taiwan, Hong Kong, Turkey, Kuwait, Qatar and Saudi Arabia.