Analysis: Breakthrough Therapies Cut Development Timeline by Two Years

Posted 11 March 2016 By Michael Mezher


A nonprofit cancer advocacy group says that the US Food and Drug Administration's (FDA) breakthrough therapy designation has been effective in shortening the amount of time it takes to develop new oncology drugs by more than two years.

In a paper published in The Pharmacogenomics Journal in March, the authors from the Friends of Cancer Research say that cancer drugs with breakthrough therapy designations also see faster approval times than non-breakthrough products as the median approval time for drugs with breakthrough designation is 2.9 months before their Prescription Drug User Fee Act (PDUFA) date, whereas the median for drugs without breakthrough designation is only 0.2 months before their PDUFA date.

The analysts also found that drugs granted breakthrough designation spent far less time in premarket development than non-breakthrough products. The analysts say the median time between submission of an investigational new drug application (IND) and a new drug application (NDA) or biologics license application (BLA) is 7.4 years for non-breakthrough products, but only 5.2 years for products with the designation.

However, breakthrough drugs were also three times more likely to receive accelerated approval, which requires additional postmarket trials to confirm a drug's effect.

Created in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), breakthrough designation is granted to products that show potential for "substantial improvement" over existing treatments and provides sponsors with more frequent communication with FDA and "intensive guidance on an efficient drug development program."

Since the creation of the designation, FDA has approved more than 30 drugs under this category, many of which are cancer therapies.

Additionally, while many oncology drugs, with and without breakthrough designation, are approved based on Phase II data, the only cancer drugs approved based on Phase I data had breakthrough designation.


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Categories: Biologics and biotechnology, Drugs, Clinical, Research and development, Regulatory strategy, Submission and registration, News, FDA

Tags: Breakthrough therapy designation, Accelerated approval, Oncology

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