 Health Care |
Health Care |
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FDA warns cancer treatments themselves linked to cancer risk |
Federal health authorities are requiring several manufacturers of CAR-T cancer therapies to add a serious warning to the prescribing information. |
© Dr. Maria Tsokos/National Cancer Institute via AP |
The required warning label comes less than two months after the Food and Drug Administration (FDA) made public an investigation into reports of T-cell malignancies — types of cancer in blood cells — including lymphoma and leukemia in people who received treatment with CAR-T therapies. CAR-T is a gene therapy that works by extracting white blood cells known as T-cells from a patient, reengineering them in a lab to attack cancer cells and then infusing them back into the body. It's used mainly to treat blood cancers such as multiple myeloma. But the therapies already carry a warning for dangerous immune responses and neurological risks. The FDA found reports of secondary cancers in about 20 patients that they suspect were caused by CAR-T treatments, but it wasn't definitive, and the agency noted more investigation was needed. The therapy was first approved in 2017 and has been used in nearly 30,000 patients. In letters sent to the manufacturers dated Jan. 19, the FDA noted the secondary cancers can lead to hospitalizations or death. The agency said the labels need to indicate the cancers "may present as soon as weeks following infusion, and may include fatal outcomes." The agency is allowing the therapies to stay on the market, a sign their benefits continue to outweigh the risks. The companies have 30 days to submit proposed changes to the label. |
Welcome to The Hill's Health Care newsletter, we're Nathaniel Weixel and Joseph Choi — every week we follow the latest moves on how Washington impacts your health. |
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How policy will be impacting the health care sector this week and beyond: |
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President Biden and his allies are looking to turn the tables on former President Trump by highlighting his mental fitness for office after a high-profile verbal slip-up at a campaign rally.
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President Biden was scheduled to meet with health care providers Tuesday for a discussion on abortion rights after the end of Roe v. Wade while in Virginia for a reelection campaign rally. Biden was set to be joined by Vice President Harris, first lady Jill Biden and second gentleman Doug Emhoff after the rally for a private discussion with providers. |
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President Biden on Tuesday directly blamed former President Trump, his likely general election opponent, for the erosion of abortion access across the country and warned supporters another Trump presidency would further curtail reproductive rights.
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Branch out with a different read: |
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Bill would revise Tennessee's decades-old law targeting HIV-positive people convicted of sex work |
NASHVILLE, Tenn. (AP) — Tennessee would no longer be the only U.S. state to impose a lifetime registration as a "violent sex offender" on anyone convicted of engaging in sex work while living with HIV under a proposal that advanced Tuesday in the legislature. The controversial statute still on the books is being challenged in federal court … | |
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Local and state headlines on health care: |
- NC Medicaid expansion already helping rural areas, state health chief says (WRAL)
- New York City looks to clear $2 billion in unpaid medical bills for 500,000 (CBS News)
- Tennessee reports 19 winter-related deaths, including three in Middle Tennessee (The Tennessean)
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Health news we've flagged from other outlets: |
- The White House has a pharmacy — and it was a mess, a new investigation found (Stat)
- Alarming 45-fold rise in measles in Europe – WHO (BBC)
- What's indoor air quality like in long-term care facilities during wildfires? Worse than you'd think. (KFF Health News)
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Most read stories on The Hill right now: |
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The State Department on Monday brushed off reports of Russian President Vladimir Putin ordering his government to look into the nation’s former … Read more |
| A federal appeals court declined an effort Tuesday by former President Trump to have his challenge to a gag order in his election interference case … Read more |
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You're all caught up. See you tomorrow! |
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