As we speak the big question is...Does Ruvidar(TLD-1433) has the criterias for BTD(Breakthrough Designation)????
First let's see what Ruvidar need for BTD.
In this article....
https://goodrx.com/healthcare-access/medication-education/fda-breakthrough-therapy Page 3...For BTD...
Preliminary evidence(data) should show the following.
1) A medication(treatment) qualifies as a breakthrough therapy if it offers
new benefits over existing treatments.
2) The treatment met its
surrogate endpoint marker that can predict a
benefit.
Note: " On the FDA site the
surrogate endpoint for Bladder cancer is " Durable objective overall response rate(ORR)".
The ORR for Ruvidar is 33%CR at 450 days.
The best treatment already available for BCG resistant patients is Keytruda at 19% CR(ORR) .
Ruvidar is 75% more potent than Keytruda.
In short Ruvidar offer a very big
benefit over Keytruda.
Back to the article...
Page3...
" The treatment is as effective as existing treatment
but safer. For exemple, a medication has a lower risk of side effects than other medication(treatments)".
We could say that with regard to safety, Ruvidar has hit a homerun(100% safe).
No other treatment come even close to Ruvidar safety(Keytruda=no, Adstiladrin=no, Valrubicin=no, Gemcitabine+Docetaxel=no).
Does the above mean that Ruvidar will get BTD???...The
preliminary evidence(data) seem to say yes...but the final word is for the FDA to decide.
With Ruvidar
preliminary Evidence(data) being more than adequate, can't wait for the FDA answer.