The U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients’ lives? In a new study, researchers found that most cancer drugs granted accelerated approval do not demonstrate such benefits within five years. “Five years after the initial accelerated approval , you should have a definitive answer,” said Dr.
Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the research. “Thousands of people are getting those drugs. That seems a mistake if we don’t know whether they work or not.' The program was created in 1992 to speed access to HIV drugs. Today, 85% of accelerated approvals go to cancer drugs. It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce better evidence before gaining full approval. Patients get access to drugs earlier, but the tradeoff means some of the medications don’t pan out. It's up to the FDA or the drugmaker to withdraw disappointing drugs, and sometimes the FDA has decided that less definitive evidence is good enough for a full approval. The new study found that between 2013 and 2017, there were 46 cancer drugs granted accelerated approva
Cancer Drugs Accelerated Approval FDA Patients Benefits Study
We have summarized this news so that you can read it quickly. If you are interested in the news, you can read the full text here. Read more:
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
New blood test shows high accuracy for colorectal cancer detection, study finds: ‘Not interchangeable’A study published in The New England Journal of Medicine says a simple blood test could detect colorectal cancer (CRC) with over 80% accuracy. The study involved 8,000 people; experts weighed in.
Source: FoxNews - 🏆 9. / 87 Read more »
Many Childhood Cancer Survivors Not Meeting Surveillance Guidelines, Study FindsMost survivors of childhood cancer don't meet surveillance guidelines that recommend screening for adult cancers or other long-term adverse effects of treatment, according to a new study. The study highlights the need for improved awareness and adherence to surveillance guidelines among childhood cancer survivors.
Source: Medscape - 🏆 386. / 55 Read more »
New Blood Test for Colorectal Cancer Shows Promise in Early Detection, Study FindsA blood test, developed by Guardant Health, was found to be 83% effective in detecting colorectal cancer in people confirmed to have the disease. Here's what you need to know about the blood test, and when it may be approved.
Source: Health - 🏆 396. / 53 Read more »
COVID pandemic led to thousands of missed prostate cancer cases, new study findsMany thousands of prostate cancer cases were missed during the disruption of the COVID pandemic, a new study has found. Dr. Marc Siegel offered insights on the findings.
Source: FoxNews - 🏆 9. / 87 Read more »
Study Finds Associations Between Dietary Factors and Colorectal Cancer RiskA nested case-control study conducted using data from 4686 patients with CRC and 14,058 matched controls reveals associations between dietary factors and colorectal cancer risk. The study also identifies genes and pathways overrepresented in the interaction between diet factors and CRC risk.
Source: Medscape - 🏆 386. / 55 Read more »
Blood test shows 83% accuracy for detecting colorectal cancer, study findsA new screening method for colorectal cancer may be on the horizon. A clinical study showed 83% accuracy for a blood test intended to detect early colorectal cancer.
Source: CBSNews - 🏆 87. / 68 Read more »