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Monday, Apr 8 2024

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Analysis Finds Half Of Accelerated Approval Cancer Drugs Don't Help

A study presented at an American Association for Cancer Research meeting showed that the drugs didn't improve patient survival or quality of life, but some even went on to be converted to full approval by the FDA. Also in the news: a link between accelerated aging and cancer risks.

For decades, the Food and Drug Administration’s accelerated approval pathway has helped companies get drugs for serious unmet medical needs to patients — and the market — sooner. But about half of cancer drugs approved via this route fail to improve patient survival or quality of life in subsequent clinical trials after more than five years of follow-up, according to new findings presented Sunday at the American Association for Cancer Research annual meeting. The data come from an analysis of cancer drugs granted accelerated approval over the past decade. In some cases, failure to show clinical benefit didn’t stop the FDA from converting accelerated approvals into full approvals, and the authors note the agency’s conversion decisions have increasingly been based on less stringent evidence of a drug’s benefits. (Wosen, 4/7)

Researchers looking for clues about why some types of cancer are on the rise in younger adults say they’ve found an interesting lead: a connection to accelerated biological aging. Aging is the major risk for many types of cancer, meaning the older you get, the more likely you are to be diagnosed. And increasingly, experts recognize that age is more than just the number of candles on a birthday cake. It’s also the wear and tear on the body, caused by lifestyle, stress and genetics, which is sometimes referred to as a person’s biological age. (Goodman, 4/7)

Ice could be the next frontier in breast cancer therapy, according to new research from Memorial Sloan Kettering Cancer Center in New York. In breast cancer patients, cold therapy was shown to be effective in freezing and destroying small, cancerous tumors in a study presented at the Society of Interventional Radiology Annual Scientific Meeting in Salt Lake City last week. Cryoablation, a minimally invasive technique, could provide a treatment alternative for patients who are not candidates for surgery, a press release stated. (Rudy, 4/5)

The U.S. Food and Drug Administration has allowed cell therapies of Johnson & Johnson and Bristol Myers Squibb to be used for treating patients in the earlier stages of a type of blood cancer, the companies said on Friday. Both J&J and Bristol Myers' therapies helped extend the time that patients lived without disease progression in late stage studies — more than when patients received 'standard of care' treatments, the companies said in separate statements. (K and Satija, 4/6)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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