RE:RE:The FDA might have no choice...Eoganacht...Thank's for the clarification, TLT competion is in worst shape than I though.
About BCG...
I did mention BCG because according to experts, the BCG shortage could last 7-10 years, and for patients it could mean being placed on a very long waiting list while there cancer is progressing.
This situation could prompt the FDA to start looking seriously for an alternative Standard Of Care treatment that doesn't rely on BCG.
The shortage of BCG could accelerate every aspects of TLT approval, not only for BCG-Unresponsive, but also for the next step NMIBC Standard Of Care.
As for the ImmunityBio 71%.CR..I found the number in this link...
https://ca.finance.yahoo.com/news/immunitybio-announces-over-24-months-221700126.html If the link doesn't work type it in your search engine.
For me it is not always easy to interpret number in some Pressrelease I may have read this 71% the wrong way.
All in all TLT is in a very enviable position right now, considering that the Standard Of Care (BCG) is in a bad situation because of the BCG shortage, and competition is in bad shape because of a lack of BCG, toxicity, or low CR%.
All the above mean the FDA may have no other choices than accelerating the approval of TLT treatment(the mandate of the FDA is to save lives).
Eoganacht wrote: Hi wildbird1 - the competition is not doing nearly as well as you wrote in your post. I think TLD1433 will have a far higher CR rate than either Keytruda or Immunobio's drug. And as you have noted TLD1433 has a far better safety profile than Keytruda and requires far fewer treatments than either of them. I wrote some comments below in red.
wildbird1 wrote: The FDA will give TLT treatment BTD(Breakthrough Designation) & AA (Accelerated Approval) only if the FDA see that there is a pressing need for TLT treatment.
Lert's see how the competition is doing...
1) BCG...
BCG is the standard of care, unfortunately there is a shortage of BCG.
https://discover.vumc.org/2021/02/bcg-shortages/will-persist/
As we speak regular patients are placed on a waiting list for BCG treatments, during that time there cancer could be progressing.
BCG is not our competition, at least not yet. Our current NMIBC trial is for BCG-unresponsive NMIBC. It is the 40% of NMIBC patients who fail to respond to BCG that is our market. Later on TLD1433 may go head to head with BCG but not yet.
2) Keytruda...
Keytruda has a 41% CR at 12 months, unfortunately Keytruda has very bad side effects.
https://keytruda.com/side-effects/
(Quote) " Keytruda can cause your immune system to attack normal organs and sometimes become severe or life threatening and can lead to death".(End Of Quote)
Nothing more need to be said about Keytruda.
Keytruda did not achieve 41% CR at 12 months - it achieved 18.75% CR at 12 months. Altogether 39 of 96 patients achieved a CR in the study. 18 of those 39 patients were still CR after 12 months, that is, 41% of the 39 CR patients or 18.75% of of the 96 trial patients.
3) ImmunityBio...
ImmunityBio has a very good CR% of 71%/24 months(2022 numbers).
Unfortunately each patient need to start with 6 treatments in six weeks of BCG+N-803 and maintenence treatments of BCG+N-803 for up to 3 years.
That is a lot's of BCG treatment for just one patient.
Because of the shortage of BCG & the high number of BCG treatments needed for just one patient, the waiting list for the immunityBio patients could be very long, and by the time BCG become available the patient cancer could be progressing.
As above the 71% CR rate is for CR at any time in the trial. The CR rate at 24 months was around 42%
TLT treatment is a stand alone treatment.
The FDA might have no choice and see that TLT treatment doesn't need BCG, has no side effects and a CR% over 70%(could much higher for the optimised patients), all the above could be a very good reason for the FDA to give TLT treatment BTD & AA much faster than expected.