FDA approves first drug targeting lung cancer with common mutation
The Food and Drug Administration approved Amgen's Lumakras drug as the first treatment for adult patients with a common form of lung cancer.
Why it matters: Non-small cell lung cancer with a specific mutation in a gene known as KRAS has been considered to be resistant to any sort of drug treatment, per the FDA. Lumakras was able to shrink the tumors of between 36% and 58% of patients studied.
What they're saying: "Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach," said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the FDA's Office of Oncologic Diseases.
Details: The drug will target specifically KRAS G12C mutations, which comprise approximately 13% of mutations in non-small cell lung cancers, which is the most common type of lung cancer.
- The approval is for a daily 960 milligram pill
- The drug "will have U.S. list price of $17,900 per month," per NBC News.
What to watch: Amgen said the FDA is requiring the company conduct a post-approval trial to see if a lower dose could have a similar effect.