Understanding the FDA’s Expedited Programs for Serious conditions (the SPECIAL STATUSES)
Focussing on the ones in Sight: FTD and BTD!
We know that Clarity will be seeking a Breakthrough Therapy Designation (BTD) for the SAR-bisPSMA products (AT told us so)! BUT -
Is 64Cu-SARTATE in the running for its own special status(es)?
What are the chances of success?
IF you have no time to read further: 64Cu-SARTATE may well be eligible for both FTD and BTD!
---- Here (below) is a bit about how these therapies qualify for these statuses (the FDA Guidance on the subject:16676fnl_Expedited Programs for Serious Conditions-Drugs and Biologics-PRA lang update.pdf. FIRSTLY, its worth stating that, right from the outset, the FDA says the following: “The programs described in this guidance are intended to help ensure that therapies for serious conditions are approved and available to patients as soon as it can be concluded that the therapies’ benefits justify their risks.” Its a 2014 document - and we know that the new team are promising to move faster!
There is a useful table that summarises what I am about to discuss (page 7);
For practicality, I have extracted only the information that is relevant to Clarity’s products - and rearranged (kept the words) it to support the approach I make in the message I am sharing. The source document is attached to this post.
Comparison of FDA’s Expedited Programs for Serious Conditions
MY OPINION: Based on the information gleaned from these FDA documents, I beleive 64Cu-SARTATE is ready and eligible for FDA Fast Track Designation (and more)!
Criteria fullfilled? YES! 64Cu-SARTATE is indeed intended to diagnose a serious condition AND clinical data just presented (DISCO) do demonstrate the potential to address what is an unmet medical need! The multiple grants of statuses such as Fast Track Designations in the same clinical indication, including the most recent one granted to Chimeric last week, (Ann. 4th of June 2025) confirms that the FDA considers NETs to be both a serious conditions, and one with an unmet medical need!
Lessons from 64Cu-SAR-bisPSMA! The first FDA Fast Track Designation (pre-prostatectomy) was on back of data from a 30 patient P1 PROPELLER trial, the second was supported by COBRA (50 patients). The third came on back of data from early cohorts on the SECURE trial. Clarity have the template - its a matter of altering drug and disease name plus a few other things!
64Cu-SARTATE has 10 patients from P1, and 45 from DISCO (total 55). And, its looking like the gap in efficacy (superiority) is quite large. 64Cu-SARTATE is certainly in the same class that pleased the FDA. SAR is the STAR!
Breakthrough Therapy Designation? Is this possible? For this, 64Cu-SARTATE would need to tick all of the FTD criteria (which it does), PLUS it should provide “… preliminary clinical evidence indicating that (it) may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies …!’ It is time for DISCO!
IN CONCLUSION: 64Cu-SARTATE is not just eligible for Fast Track Designation, but it also fulfils the eligibility criteria for the grant of FDA Breakthrough Therapy Designation as well! Clarity will , of course have to apply for all of this, and wait for an anwer from the FDA!
[AND: YES, by the same criteria, 64Cu-SAR-bisPSMA fulfills the conditions for Breakthrough Therapy Designation, and perhaps even more]
If you prefer webpages: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
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