FDA approves first drug that targets common lung cancer mutation

Oriana Gonzalez
·1 min read

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.

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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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