OBJECTIVES: Since 2013, Food and Drugs Administration (FDA) Breakthrough Therapy status has enabled expedited development and review of therapies where preliminary evidence suggests substantial clinical improvements for serious/life-threatening conditions. However, there was a pre-existing FDA expedited pathway: Accelerated Approval enabling market entry of drugs for serious conditions based on a surrogate endpoint likely to predict clinical benefit with confirmatory trials completed post-approval. This abstract aims to compare access of therapies under both pathways to determine in which distinct circumstances they are being used METHODS: All FDA approvals from January 2013-March 2015 were screened for any approvals under Breakthrough Status and/or Accelerated Approval and the disease areas and supportive data packages were extracted. RESULTS: Since November 2013, when the first therapy was approved under Breakthrough status, 13 drugs have been FDA-approved under Accelerated Approval and 21 under Breakthrough Status including 8 supported by both expedited programs. For the 14 approvals under Breakthrough Status alone, 11 (79%) were supported by Phase 3 data with the remaining 3 (21%) supported by Phase 2. Of the 6 drugs under Accelerated Approval alone, 2 (33%) were approved on Phase 3 data with the remaining 4 (66%) supported by Phase 2. Of the 7 approved under both programs, only 1 (14%) was supported by Phase 3 data, 4 (57%) by Phase 2 data and 2 (29%) by only Phase 1 data. 86% (12/14) Breakthrough Status alone approvals were for non-oncology drugs versus just 16% (1/6) for Accelerated Approval alone and 0% (0/7) for under both programs. CONCLUSIONS: Whereas Accelerated Approval is typically used for oncology drugs, Breakthrough Status has been frequently applied to non-oncology medicines. Accelerated Approval also frequently enables expedited access without available supporting Phase 3 data, unlike Breakthrough Status. Products with supported by both programs have gained access supported by only Phase 1 data.