FDAnews
www.fdanews.com/articles/159856-fda-approves-first-drug-under-breakthrough-therapy-pathway

FDA Approves First Drug Under Breakthrough Therapy Pathway

November 5, 2013
The FDA Friday approved the first drug under its breakthrough therapy pathway, one year after it began accepting applications in the category. Genentech’s leukemia drug Gazyva (obinutuzumab) was the first to win approval and was one of 30 applications the FDA awarded the designation to out of 100 applications it received.
Drug Industry Daily