“The FDA approval of Lumakras is a breakthrough moment for patients with KRAS G12C-mutated non-small cell lung cancer because there is now a targeted therapy for this common, but previously elusive, mutation,” Dr. David Reese, Amgen’s executive vice president of research and development, said in a statement.
KRAS G12C mutations account for about 13 percent of mutations in non-small cell lung cancers. Mutant KRAS has built a reputation within the cancer research community as being undruggable due to its unorthodox shape as a protein.
Lumakras’ path to U.S. regulatory approval took less than three years to complete. The FDA is requiring that a post-marketing trial be conducted to determine if a lower dose will yield a similar clinical effect.
The drug is taken as oral tablets. According to NBC, the drug’s U.S. list price will be $17,900 per month.
Shares of Thousand Oaks-based Amgen (AMGN) closed Thursday up 2 percent to $244.64 on the Nasdaq.