FDA Approves Drug Targeting KRAS Mutation For First Time

The FDA gave its first approval today of a cancer drug that targets a KRAS mutation.

The agency's OK of Amgen’s Lumakras (sotorasib) for previously treated non-small cell lung cancer (NSCLC) might usher in a new era of oncology medications because KRAS mutations are found in many different types of cancer. Although common, there has been some question about how “druggable” KRAS mutations are because researchers have had difficulty developing a drug that targets them.

The Wall Street Journal reported that Amgen will charge $17,900 a month for Lumakras, an oral drug, and that analysts are saying it has the potential to be a blockbuster (annual sales of $1 billion or more).

But the newspaper also reported that a Ronny Gal, a prominent analyst at Sanford Bernstein, said in a note last week that the commercial prospects for Lumakras were uncertain because it may not add much benefit beyond current treatments and that it may face competition from other medications targeting KRAS mutations.

Lumakras targets a particular KRAS mutation called G12C. Amgen said in the press release it put out today announcing the approval that about 13% of patients with nonsquamous NSCLC in the U.S. have the KRAS G12c mutation.

The company's announcement says that the FDA approval was based on results from a subset of patients in the CodeBreaK100 clinical trial that enrolled patients with KRAS G12C mutation. Amgen announced in October 2020 that it had positive results from the CodeBreaK100, and today’s press release says that the trial showed efficacy and tolerability in 124 patients with KRAS G12C mutation-positive NSCLC who had disease progression after receiving an immunotherapy, chemotherapy or both.