Learning from the FDA breakthrough therapies pathway

The expedited USA Food and Drug Administration regulatory pathway for 'breakthrough therapies' has already yielded its first two approvals and more than 26 designations, for 30 candidates in 22 indications. Less than a year on, on 1 November 2013, obinutuzumab became the first drug to graduate from the breakthrough therapy programme into the real world. Weeks later, it was joined by ibrutinib. The breakthrough era has arrived, wrote Asher Mullard in an article published in the Nature Reviews Drug Discovery. Read more here.

Study mentioned: Mullard A. Learning from the 2012-2013 class of breakthrough therapies. Nat Rev Drug Discov. 2013 Nov 29;12(12):891-3. PMID: 24287765