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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.

Go deeper

Aug 31, 2021 - Health

Google data: FDA approval nudged more vaccine interest

Expand chart
Data: Google Trends; Chart: Jared Whalen/Axios

Full FDA approval of the Pfizer vaccine appeared to drive an uptick in intent about getting vaccinated, though it wasn't as impactful as the COVID-19 surge or vaccine mandates, Google Trends data suggests.

Why it matters: The FDA approval is one of the last levers the Biden administration has been hoping would prod the vaccine-hesitant.

11 mins ago - World

"I assume full responsibility," Duterte says of drug war

Rodrigo Duterte in 2017. Photo: Linus Escandor II/AFP via Getty Images

Philippines President Rodrigo Duterte said Thursday that he assumes full responsibility for a violent war on drugs that has killed thousands of people, Reuters reported.

Why it matters: Last month the International Criminal Court (ICC) formally authorized an investigation into alleged crimes against humanity during Duterte's war on drugs.

CDC approves boosters for Moderna and J&J and mix-and-match

Boxes containing vials of the Janssen COVID-19 vaccine. Photo: Jon Cherry/Getty Images

The Centers for Disease Control and Prevention's independent advisory panel voted unanimously to recommend booster doses of Moderna and Johnson & Johnson vaccine for certain populations and allow people to mix-and-match doses.

The big picture: The agency aligns with the Food and Drug Administration authorization Wednesday night which said people could switch to whichever vaccine they wanted for their booster shot.