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- Breakthrough_therapy abstract "Breakthrough Therapy designation is a United States Food and Drug Administration expedited drug development tool, which allows the FDA under Section 902 of the July 9, 2012 Food and Drug Administration Safety and Innovation Act, to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.A breakthrough therapy designation can be assigned to a drug if "it as a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development."Critics complain that most of these drugs are not actually “breakthroughs,” because they are based on preliminary evidence, including changes in surrogate markers such as laboratory measurements, that often don't reflect "meaningful clinical benefit." Even when they do, many of these benefits are not eventually confirmed in large clinical trials. And calling a drug a "breakthrough" drug gives the drug a marketing advantage which makes people believe that it is more effective than it actually is.According to the FDA, in 2013 breakthrough therapy designations were assigned to Obinutuzumab, Ibrutinib and Sofosbuvir. In 2014 Ivacaftor, Ofatumumab, Ceritinib, Idelalisib, Ibrutinib (2nd approval), Eltrombopag, Pembrolizumab, Ledipasvir/Sofosbuvir, Nintedanib, Pirfenidone, Blinatumomab, Viekira Pak ombitasvir, paritaprevir, ritonavir and Nivolumab received the breakthrough therapy designation in 2014. In 2015 Ibrutinib (3rd approval) and Palbociclib received FDA breakthrough therapy designation.".
- Breakthrough_therapy wikiPageID "45597229".
- Breakthrough_therapy wikiPageLength "3949".
- Breakthrough_therapy wikiPageOutDegree "29".
- Breakthrough_therapy wikiPageRevisionID "683089771".
- Breakthrough_therapy wikiPageWikiLink Blinatumomab.
- Breakthrough_therapy wikiPageWikiLink Category:Breakthrough_therapy.
- Breakthrough_therapy wikiPageWikiLink Category:Pharmacy.
- Breakthrough_therapy wikiPageWikiLink Ceritinib.
- Breakthrough_therapy wikiPageWikiLink Clinical_trial.
- Breakthrough_therapy wikiPageWikiLink Combination_therapy.
- Breakthrough_therapy wikiPageWikiLink Eltrombopag.
- Breakthrough_therapy wikiPageWikiLink Food_and_Drug_Administration.
- Breakthrough_therapy wikiPageWikiLink Food_and_Drug_Administration_Safety_and_Innovation_Act.
- Breakthrough_therapy wikiPageWikiLink Ibrutinib.
- Breakthrough_therapy wikiPageWikiLink Idelalisib.
- Breakthrough_therapy wikiPageWikiLink Ivacaftor.
- Breakthrough_therapy wikiPageWikiLink Ledipasvir.
- Breakthrough_therapy wikiPageWikiLink List_of_drugs_granted_breakthrough_therapy_designation.
- Breakthrough_therapy wikiPageWikiLink Nintedanib.
- Breakthrough_therapy wikiPageWikiLink Nivolumab.
- Breakthrough_therapy wikiPageWikiLink Obinutuzumab.
- Breakthrough_therapy wikiPageWikiLink Ofatumumab.
- Breakthrough_therapy wikiPageWikiLink Ombitasvir.
- Breakthrough_therapy wikiPageWikiLink ritonavir.
- Breakthrough_therapy wikiPageWikiLink Palbociclib.
- Breakthrough_therapy wikiPageWikiLink Paritaprevir.
- Breakthrough_therapy wikiPageWikiLink Pembrolizumab.
- Breakthrough_therapy wikiPageWikiLink Pirfenidone.
- Breakthrough_therapy wikiPageWikiLink Ritonavir.
- Breakthrough_therapy wikiPageWikiLink Sofosbuvir.
- Breakthrough_therapy wikiPageWikiLink Viekira_Pak.
- Breakthrough_therapy wikiPageWikiLinkText "Breakthrough Therapy Designation".
- Breakthrough_therapy wikiPageWikiLinkText "Breakthrough therapy".
- Breakthrough_therapy wikiPageWikiLinkText "breakthrough therapy".
- Breakthrough_therapy hasPhotoCollection Breakthrough_therapy.
- Breakthrough_therapy wikiPageUsesTemplate Template:Pharmaceutical_industry_in_the_United_States.
- Breakthrough_therapy wikiPageUsesTemplate Template:Reflist.
- Breakthrough_therapy subject Category:Breakthrough_therapy.
- Breakthrough_therapy subject Category:Pharmacy.
- Breakthrough_therapy hypernym United.
- Breakthrough_therapy type Concept.
- Breakthrough_therapy comment "Breakthrough Therapy designation is a United States Food and Drug Administration expedited drug development tool, which allows the FDA under Section 902 of the July 9, 2012 Food and Drug Administration Safety and Innovation Act, to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.A breakthrough therapy designation can be assigned to a drug if "it as a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development."Critics complain that most of these drugs are not actually “breakthroughs,” because they are based on preliminary evidence, including changes in surrogate markers such as laboratory measurements, that often don't reflect "meaningful clinical benefit." Even when they do, many of these benefits are not eventually confirmed in large clinical trials. ".
- Breakthrough_therapy label "Breakthrough therapy".
- Breakthrough_therapy sameAs m.012zf2yy.
- Breakthrough_therapy wasDerivedFrom Breakthrough_therapy?oldid=683089771.
- Breakthrough_therapy isPrimaryTopicOf Breakthrough_therapy.