FDA has created a new classification of drugs called Breakthrough Therapies. This program allows therapies for life-threatening diseases that show early promise to be candidates for faster FDA approvals. One of the challenges that has been identified with the Breakthrough program is that many of those already identified as Breakthrough have companion diagnostics that need to be used to ensure the drug is given to the appropriate patients. The concern is that, if drug timelines are shortened, will the CoDx products be able keep up, and wlll there be a PMA approved at the same time?
Friends of Cancer Research (FOCR) has been integral in moving the Breakthrough Therapy program forward. The organization has stepped up again to help ensure the Dx companions don't get left behind.
During a meeting held on Friday, September 6th, FOCR presented five proposals that suggest ways FDA may be able to take risk-based approaches that wil allow for faster approval of CoDx's associated with Breakthroughs, without compromising standards or holding up important new therapies for patients. The proposals were well received both by industry and FDA. FDA particularly seemed to appreciate the risk-based proposals, as this is consistent with how decisions are currently made during the review process.
The comments on the proposals were positive enough that I would encourage anyone that has a companion associated with a Breakthrough to utilize the worksheet that goes along with the paper to frame discussions during the pre-submission process.