Shares of Amgen (AMGN) - Get Amgen Inc. Report got a boost Friday after the U.S. Food and Drug Administration cleared it to market Lumakras, a drug that treats a non-small cell lung cancer with a specific mutation gene known as KRAS.
"KRAS has challenged cancer researchers for more than 40 years with many deeming it as 'undruggable,'" Amgen Executive Vice President of Research David Reese said in a statement.
"The LUMAKRAS development program was a race against cancer for Amgen's scientists and clinical-trial investigators who together have now successfully delivered this new medicine to patients in less than three years -- from first patient dosed to U.S. regulatory approval."
Amgen shares at last check were up 1.2% at $238.23.
The drug shrank tumors with the KRAS mutation in about 36% of patients in clinical trials. Amgen will list the drug at $17,900 per month in the U.S.
Adverse reactions resulting in permanent discontinuation of the treatment during trial occurred in 9% of patients.
Non-small-cell lung cancer accounts for about 84% of the 2.2 million new lung cancer diagnoses each year, including about 236,000 new cases in the U.S. annually, Amgen said.
Last month, the FDA proposed that the once-daily treatment be compared with a lower daily dose of the drug. Amgen agreed with the suggestion and said that it expected results from that study in late 2022.
Amgen says Lumakras, taken by mouth, is a small-molecule inhibitor that treats patients with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer.
In March, the company said it was buying Five Prime Therapeutics for $1.9 billion to beef up its cancer-drug pipeline.