The increase in FDA-approved novel cancer drugs over the last 5 years: What factors are involved?

e14111Background: In 2015, The FDA approved the most number of novel drugs in the last 19-years. We propose to evaluate the factors associated with the significant increase in FDA approved oncologic drugs over the last 5 years. Methods: Data was extracted from all novel drug license applications to the FDA. SAS was used to conduct Chi-squared tests. Results: The FDA approved 47 novel cancer drugs from 2011 to 2015, of which, 34 (72.3%) were new drug applications and 13 (27.7%) were biologic license applications. Of these, 35 (64.5%) were orphan and 19 (40.4%) were first-in-class drugs. Based on expedited approval, 36 (76.6%) underwent priority review, 27 (57.5%) fast track, 17 (36.2%) accelerated, and 11 (23.4%) had breakthrough designation. 31 (66%) were for solid and 16 (34%) for liquid cancers. 20 (42.6%) drugs were approved based on clinical response, 16 (34.0%) on progression-free survival and 11 (23.4%) on overall survival as primary endpoints. The median time from initiation of clinical trial to ap...