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The idea of a breakthrough therapy was promoted to speed approvals of medicines that held promise for treating a life-threatening disease and demonstrated substantial improvement over existing drugs. However, a new study finds that while cancer drugs considered to be breakthroughs were approved more quickly, they were not safer, more novel, or more effective than drugs not given this designation.

The study examined 58 new cancer medicines that were approved by the Food and Drug Administration between 2012 and 2017. Of these, 25 — or 43 percent — received breakthrough therapy designation. The median time to a first FDA approval was 5.2 years for drugs that given a breakthrough designation versus 7.1 years for cancer medicines that were not considered to be breakthroughs.

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  • What nonsense is this, insisting “for real world evidence” rather than simply accepting the outcome$ of a defined process? How’s a pharma unicorn supposed to make a billion or two?
    Meanwhile, among other items in shortage, sterile water is an on-going problem according to FDA – I wonder if it’s because there are “no billions in that?”

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