We will be sharing some data on 2005 to 2014 oncology approvals, including the size of the trials cited in the medical review, and the orphan status.
The spreadsheet we are working on updating is published here:
The basic take home messages are (1) that the trials are much smaller than the average for all new NME and BLA drug approvals, and (2) the Orphan Drug tax credit is quite important, since most of the new cancer drugs are approved as orphans, and also have subsequent Orphan designations. The statistics are calculated on the bottom of the spreadsheet.
Size of Trials
We have data on the 42 new oncology drugs approved by the FDA from 2005 to 2014 as NME or BLAs, for which we have complete data on the trials cited in the Medical review:
Patients in trials cited in Medical Review, 42 drugs with complete data.
Average: 1,173
Median: 993
When we add in 7 products for which we have partial, but incomplete data, the averages and median are:
Patients in trials cited in Medical Review, 42 drugs with complete data, 6 with incomplete data
Average: 1,582
Median: 1,125.
Orphan Status
For all 49 products, the Orphan status is as follows:
Orphan when approved: 28, 57%
Drugs with at least one orphan designation: 38: 78%