Elaine Thompson / AP

The FDA has approved the first advanced therapy to attack cancer. The brand-name drug, Kymriah, made by pharmaceutical giant Novartis, can be used for children and young adults who have a certain form of leukemia.

Why it matters: It's a major approval that has the potential to change how cancer is treated, although the eligible patient population appears small for now. "We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer," FDA Commissioner Scott Gottlieb said in a statement.

What the drug does: It's commonly known as a CAR-T therapy, and it's a hot research area across several drug companies (and is the prize of Gilead's $11.9 billion buyout of Kite Pharma from this week). CAR-T modifies a patient's immune cells, which are then infused back into the patient to kill cancer cells.

The price: $475,000 for a one-time treatment, according to a conference call with Novartis executives. The company also said it will only accept payments if patients respond to the drug within the first month. David Mitchell, president of advocacy group Patients For Affordable Drugs, met with Novartis yesterday to talk about "how to arrive at a fair price for its new CAR-T drug," but said the meeting was "disappointing."

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Updated 1 hour ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Politics: Ex-FDA chief: Pence campaigning after COVID exposure puts others at risk — Mark Meadows: "We are not going to control the pandemic"— COVID-19 looms over White House Halloween celebrations.
  2. Health: 13 states set single-day coronavirus case records last week — Fauci says maybe we should mandate masks if people don't wear themU.S. reports over 80,000 new cases for second consecutive day.
  3. World: Italy tightens restrictions Spain declares new state of emergency.

Amy Coney Barrett's immediate impact

Illustration: Eniola Odetunde/Axios

In her first week on the job, Amy Coney Barrett may be deciding which votes to count in the presidential election. By her third week, she’ll be deciding the fate of the Affordable Care Act.

Where it stands: The Senate votes on Barrett’s nomination tomorrow. If she’s confirmed, Chief Justice John Roberts is expected to swear her in at the Supreme Court within hours, an administration official tells Axios.

Texas Democrats beg Biden to spend now

Photo: Ron Jenkins/Getty Images

The Biden campaign is rebuffing persistent pleas from Texas Democrats to spend at least $10 million in the Lone Star state, several people familiar with the talks tell Axios.

Why it matters: If Texas — which has 38 electoral votes and is steadily getting more blue, but hasn't backed a Democrat for president since 1976 — flipped to the Biden column, it would be game over. But the RealClearPolitics polling average stubbornly hovers at +2.6 for Trump — and Team Biden appears more focused on closer targets.

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