January marked two approvals for Amgen Inc.’s Sotorasib, a treatment for a mutation of advanced non-small cell lung cancer (NSCLC) that has progressed after systemic therapy.
Sotorasib was approved by the European Commission earlier this month and approved in Japan less than two weeks later. Sotorasib is branded as Lumykras in Great Britain and the European Union. Contrastingly, in Japan, the United States and other countries, it is called Lumakras.
“Today’s approval of Lumakras as the first and only KRAS G12C inhibitor marks a paradigm shift in the treatment of patients with non-small cell lung cancer in Japan,” Dr. David Reese, Amgen’s executive vice president of research and development, said in a statement.
It has been a little more than three years since the first patient was dosed in CodeBreak 100, the treatment’s Phase I and II trials. Sotorasib is now approved in nearly 40 countries with Japan’s OK.
“KRAS gene mutations are one of the oldest known cancer driver gene mutations,” Steve Sugino, president and representative director of Amgen K.K., the company’s Japanese subsidiary, said in a statement. “However, it has proven to be very difficult to develop drugs for the treatment of KRAS gene mutations.”
Researchers deemed the mutation as undruggable for about 40 years.
Sotorasib was the first KRAS G12C inhibitor to receive regulatory approval anywhere in the world when it received accelerated approval in the United States in May 2021.
In Amgen’s last earnings report, when Sotorasib had yet to receive approval from several of the countries it is now cleared in, the treatment accounted for $36 million in net sales. The November earnings report stated that Sotorasib had been prescribed by more than 500 physicians in both academic and clinic settings.