FDA approves drug Amgen for lung cancer with specific mutation
Robert Galbraith | Reuters
The U.S. Food and Drug Administration on Friday approved an Amgen drug for non-small cell lung cancer with a specific mutation in a gene known as KRAS in patients whose disease worsened after treatment with chemotherapy or other drugs.
The drug, sotorasib, which will be sold under the brand name Lumakras, has shrunk tumors with the KRAS mutation in about 36% of patients in clinical trials.
Amgen said the drug will have a US list price of $ 17,900 per month.
The medicine is designed to target a gene mutation known as KRAS G12C which occurs in about 13% of non-small cell lung cancers (NSCLC), the most common type of lung cancer.
Amgen estimates that approximately 25,000 US patients per year will be eligible for the drug. The KRAS mutation is also found in 1% to 3% of colorectal and other cancers.
The approval, which comes more than two months ahead of the FDA’s target decision date, is for a 960 milligram daily pill.
The agency is also asking Amgen to conduct a post-approval study to see if a lower dose might be effective.
Cancer drugs are usually developed in the highest tolerable dose, but some oncologists have urged the FDA to do more to force drugmakers to optimize dosage.
“Our feeling is that this is going to become more common in oncology,” Amgen chief research officer David Reese told Reuters in a telephone interview.
Lumakras is part of a growing trend for precision drugs that target genetic mutations that cause cancer, regardless of which organ the disease originates from.
Reese said Amgen is studying Lumakras in combination with other drugs as an initial treatment for patients with NSCLC who have the KRAS mutation, as well as for other types of cancer.
Amgen is also seeking regulatory approval for the drug in Europe, Japan and several other jurisdictions, he said.