The Next Phase In Oncology: FDA’s Pazdur On “Breakthrough” Drug Development
This article was originally published in RPM Report
At a small press briefing on personalized medicine, FDA’s top cancer drug reviewer paints a picture of the next phase in cancer drug development.
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FDA’s decision to seek the withdrawal of Ariad’s Iclusig prompted concerns about greater caution by the agency in the “Breakthrough” era. A more important implication, however, may be in whether the continued access program succeeds in meeting demand for the product. That could become a model for future development of ever-more personalized cancer treatment regimens.
A new FDA designation process for “breakthrough” drugs is one of the few “innovation” features of the FDA Safety & Innovation Act. It is likely to be very attractive to biotech sponsors, though its impact on actual product approvals is uncertain at best. The real “breakthrough,” though, may be in the collaborative model that led to the legislation – and that is an important message for sponsors hoping for bigger reforms ahead.
Swing for the Fences: FDA's Top Cancer Drug Official Urges "Home Run" Trial Designs for Targeted Therapies
When Richard Pazdur discussed ideas for a National Cancer Policy at an IoM event, one theme was unmistakable: if sponsors really believe what they say about targeted therapies for cancer, they should aim high with their clinical trial designs and endpoints.