New cancer drugs take up to two years longer to be made available in Australia compared to countries such as the US because of the lack of a ‘fast track’ regulatory approval process, a study has shown.
A review of 128 new drugs for cancer developed since 2007 found that they were approved an average of 17 months (range 14-22 months) later in Australia subsequent to FDA approval.
In a comparison of regulatory approval times for several jurisdictions, the TGA was the second longest in terms of delays after FDA approval, trailing behind the European Medicines Agency (9.7 months), Canada (12.2 months) and Switzerland (15.7 months), but ahead of Japan (37.4 months).
The review found that overall regulatory review times for cancer drugs were not much longer in Australia compared to the US (12 months vs 10 months). Instead, the later approval times were often caused by delays in pharmaceutical companies submitting applications to the TGA and [until 2017] the lack of an expedited approval process for cancer drugs.
Writing in JCO Oncology Practice, the study authors noted that most new cancer drugs approved by the FDA (91%) and Health Canada (59%) qualified for at least one expedited program within those jurisdictions, compared with 46% of EMA approvals and only 12% of TGA approvals after 2017.
Drugs assessed under the expedited process took around six months to gain approval in the US, and likewise the TGA’s priority review pathway introduced in2017 accelerated approval times from 11.5 months to 6.2 months.
The review also found that the accelerated approval programs were not prioritising cancer drugs with the most clinically meaningful benefits. There was no association between shorter review time and a drug’s score on the ESMO-Magnitude of Clinical Benefit Scale (MCBS).
The study authors from the Dana-Farber Cancer Institute, Boston, said delays in cancer drug approvals may be improved by the recent introduction of trans-jurisdictional programs to jointly review and approve new medicines such as the 2018 New Chemical Entities Work Sharing Initiative, which includes Australia.
“The first products approved by this consortium were cancer therapies, namely, apalutamide (prostate cancer), abemaciclib (breast cancer), and niraparib (ovarian, fallopian tube, or peritoneal cancers),” they noted.
And with regulators such as the TGA now adopting expedited approval programs the findings showed there is a need to base these on a validated value framework, such as ESMO’s MCBS, “to better prioritise faster review for drugs with high clinical benefit,” they advised.