May 29, 2021 - Health

FDA approves first drug targeting lung cancer with common mutation

FDA headquarters

Food And Drug Administration Headquarters In Maryland. Photo: Michal Fludra/NurPhoto via Getty Images

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.

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