........
Anything that can delay or even completely avoid the removal of the bladder will be given an
, given how major is the removal of a bladder. Why would the FDA delay such accelerated approval, given the low side effect of our treatment? That's probably the kind of guidance that the FDA gave to TLT.
It's all about given patients new alternatives, so they can keep their bladder or delay such complicated surgery that is a cystectomy.
No doubt our treatment qualifies so far.
wildbird1 - (11/27/2022 12:32:25 PM)
RE:RE:N-803 had been granted Breakthrough designation. We will too
ScienceFirst great catch...(the best catch I have seen lately).
If we sum-up, for the FDA, the new goal for NMIBC patients(like TLT patients) would be
Avoiding Cystectomy(removal of the bladder).
The above is one more proof as to why TLT has always included a TR%(CR+PR) line in their NewsRelease data.
PR Patients.
Partial response patients are patients that still have their cancer, but the tumor has gotten smaller(30-50%), and the tumor is not growing. If you are a PR patient, it does mean you can keep your bladder(
avoid cystectomy), and take a break from treatment, as long as the tumor doesn't start to grow again.
For some patients, PR can last a lifetime( almost as good as a CR patients).
https://webmd.com/cancer/remission-what-does-it-mean To sum-up, TR% is the number of patients that have achieved the FDA goal of
Avoiding Cystectomy. Let's see what could be the TR% for the optimized patients group.
From the 3Q2021 NewsLetter.
TLT has received the data on 11 optimized patients(18-7 pending=11 patients).
CR...............8/11............73%
PR...............2/11............18%
TR..............10/11............91% NR................1/11..............9%
At 90 day, 91% of optimized patients have achieved the FDA goal of
Avoiding Cystectomy. Note; There is absolutely no way the FDA will waste time and energy on 12 undertreated patients that have received the wrong treatment protocol(it would be counterproductive).
No! The FDA will focus on the optimized treatment protocol that save lives and bladders.
And if at 450 day(Dec 22), the optimized patients group has achieved a very high TR%, you can bet your shirt that the FDA&TLT will have a serious talk about such a high number of optimized patients that have achieved the FDA goal of
Avoiding Cystectomy.
The FDA may have no choice, but to give TLT, BTD and AA(Accelerated Approval) for commercialization as soon as possible(2023), to save more bladders and lives.
ScienceFirst wrote:It's impossible that TLT not be granted Breakthrough designation when you read carefully the news release of ImmunityBio's of Dec. 2019, as we clearly see the goal of the FDA:
Dec. 4, 2019:
ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer Results of Phase 1 and 2 studies in BCG Unresponsive Non-Muscle Invasive Bladder Cancer in High Risk Carcinoma in Situ Disease Earn FDA Breakthrough Status for ImmunityBio’s IL-15 Superagonist Complex The FDA published guidance in February 2018 to address BCG unresponsive NMIBC, stating that the goal of therapy in patients with BCG-unresponsive NMIBC is to avoid cystectomy. The Urgent, Unmet Need to Treat NMIBC and Avoid Cystectomy
Bladder cancer has a high incidence worldwide, with 199,922 deaths and an estimated 49,393 new cases in 2018. 2 In the United States, bladder cancer is the fourth most commonly diagnosed solid malignancy in men and the twelfth for women; The American Cancer Society estimates 80,470 new cases and 17,670 deaths in 2019. 3 Bladder cancers are described based on how far they have invaded into the wall of the bladder. NMIBC occurs when the cancer has not grown into the main muscle layer of the bladder. Approximately 75-85% of all newly diagnosed cases of bladder cancer are non-muscle invasive bladder cancer (NMIBC).4
For the last 30 years, BCG immunotherapy has been the standard for treating NMIBC. However, disease recurrence and progression rates remain unacceptably high. Standard of care recommendations for these patients include lifetime invasive surveillance and rapid treatment of recurrences, creating a substantial financial burden and drastic impact on quality of life. Of those patients who experience recurrence, approximately 30% will progress and succumb to their disease over a 15-year period, and another 50% will undergo radical cystectomy of the bladder in an attempt to control their disease. 5
For high-risk NMIBC patients who are BCG-unresponsive with persistent or recurrent disease, treatment guidelines recommend a surgical procedure called radical cystectomy, a surgery to remove the entire bladder that may require removal of other surrounding organs. In men, removal of the prostate may be necessary, and in women, surgeons may also remove the uterus, fallopian tubes, ovaries and cervix, and occasionally a portion of the vagina. Despite the advent of minimally invasive procedures and robotic techniques, the 90-day mortality and morbidity rates in patients who undergo cystectomy remain unacceptably high at 5.1-8.1% and 28-64%, respectively. 6 Based on this urgent need, FDA published guidance in February 2018 to address BCG unresponsive NMIBC, stating that the goal of therapy in patients with BCG-unresponsive NMIBC is to avoid cystectomy.
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