Theralase Technologies Inc. V.TLT

Accelerated Approval

[Eoganacht]

According to a page on their website the FDA does not set the bar very high for accelerated approval:

"...instead of having to wait to learn if a drug actually extends survival for cancer patients, the FDA may approve a drug based on evidence that the drug shrinks tumors, because tumor shrinkage is considered reasonably likely to predict a real clinical benefit."

TLD1433 pdt does not just shrink tumours - it destroys them and completely eradicates the cancer of NMIBC patients to a greater extent than currently approved treatments. In other words, TLD1433 pdt has not just provided evidence that it is reasonably likely to provide a real clinical benefit, it has provided evidence of a real clinical benefit itself (a durable complete response) in one third of the patients 12 months after their first treatment. And this has happened almost one third of the way through the trial (31 out of 100 patients).

The FDA on clinical benefits:

"A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as “clinical benefit”.

Is there any doubt about whether or not TLD1433 pdt has already achieved this?

                            Keytruda    Adstiladrin    TLD1433 Current   TLD1433 Projected
CR at any time         41%            51%                    60%                       69%
Durable CR              19%            24%                    28%                       38%

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval

[BlueFranky]

Bang on Eoganacht.. great post!

[N0taP00p]

Eoganacht,. Adstiladrin FDA release says  this: "Overall, 51% of enrolled patients using Adstiladrin therapy achieved a complete response (the disappearance of all signs of cancer as seen on cystoscopy, biopsied tissue, and urine). The median duration of response was 9.7 months. Forty-six percent of responding patients remained in complete response for at least one year.". 

[Eoganacht]

51% achieved a CR at any time. 46% of that 51% were still CR at one year. 46% of the 51% of responding patients = 24% of the evaluable patient population.

[N0taP00p]

Thanks Eoganacht. Does that 24% calc (46% of 51% CR at any point)  compare apples to apples with the 28% CR for TLT?  I ask because I don't remember seeing that calc.  28% is a 450 day CR number for TLT, right?  

[Eoganacht]

It's not apples to apples. Although TLD1433 outdid Adstiladrin's CE rate by 4 percentage points this was also at a 3 months longer duration.

[gojotv!]

...to say nothing of Ruvidar's low toxicity, ease and infrequency of treatments. If TLD-1433 were administered anywhere near as often as other treatments, its efficacy would surely skyrocket.