TGA approval timelines for new cancer medicines

MAESTrO Database

13 February 2017 - The publication of submission dates in the TGA's Annual Report for 2016 enables more insightful analysis of TGA approval timelines.

The TGA approved 11 new cancer medicines in 2015; the mean time from the date of initial submission to the date of TGA approval was 382 days (median = 315 days).   The shortest period was for ibrutinib (196 days) and the longest period was for pralatrexate (1019 days). Both of these medicines remain rejected by the PBAC.

The TGA approved the same number of new cancer medicines in 2016,  but with a slightly shorter mean (375 days) but a longer median (366 days). The shortest period was for olaparib (310 days) and the longest period was for panobinostat lactate (504 days). Olaparib was listed on the PBS on 1 February 2016; the PBAC is yet to consider a submission for panobinostat lactate.

Read TGA Annual Report for 2016

Michael Wonder

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Michael Wonder