Thank you for getting the information. It sounds like patients living in the UAE will not experience a BCG shortage. That is great. I have been following the BCG shortage issue for almost 3 years.
I think having multiple sources is the only way to minimize the risk of shortage as the BCG manufacturing process is prone to have a problem as it deals with live bacteria.
BCG is BCG as different BCG manufacturers around the world imported their original seed from the Pasteur Institute in Paris, France. A case in point, when the BCG shortage had happened in 2012 because the company Sanofi Pasteur suspended the production of Connaught strain in their manufacturing facility in Canada, Merck had to ramp up their Tice strain BCG in a single production line in Durham, NC. Many European countries were using Connaught strain BCG and they faced the BCG shortage. So, the European Association of Urology (EAU) issued the guideline to deal with the shortage. The guideline stated "The published meta-analysis of prospective randomized trials did not suggest any difference in efficacy of the BCG strains (Pasteur, Frappier, Connaught, TICE, RIVM). In patients with Ta T1 tumors at high risk of progression or with CIS who are unfit to or unwilling to undergo a cystectomy, there is no scientifically proven alternative to BCG treatment. Thus every effort should be made to obtain an available BCG strain".
Personally, I do not understand why the FDA does not expertise the approval of the Phase III trial of Tokyo-172 BCG, which is running since 2016. I understand that near 800 patients have been on the trial already. The target was 969 patients. So, they should have enough clinical data for the Tokyo-172 strain BCG.
My concern is that the estimated primary completion date of the clinical trial is Feb 2022 and the estimated study completion date is 2025. The estimated completion date of MERCK's new production facility is 5-6 years away. It means we will actual shortage, which is happening now according to some postings in this forum, and risk of continuing shortage for next 3-5 years. This is a big concern.
Incidentally, MERCK sells a vial of freeze-dried 50 mg ONCO-TICE BCG for $150. It looks like CISPA sells its freeze-dried 40mg ONCO-BCG for RS 740, which is equivalent to US$10 according to a medical supply website.
UAE is getting drug imported from different countries. If there is shortage with one company they have redundancy. BCG here is from Cipla.
They get huge drug imported from Germany, India, and US as well.
Thanks for the clarification. If you ever have a chance to talk to the urologist, can you find out which company's BCG they are using in UAE. As you know we have been experiencing a BCG shortage in North America. Here in North America, MERCK is supplying Tice Strain BCG. I am curious to know if the UAE is also experiencing a BCG shortage.
I appreciate your response. I talked to pathologist and he said , generally if any tumor has about ~10% undifferentiated cells , we consider it as low grade. Since in our case these cells were more than 10% and around 20% hence we consider your dad's tumor as HG, and rest of all the resected tumor was LG.
During my research , I came across one study which say mixed mode HG LG. This is a class of grade which has some resemblance and parallels LG tumors in clinical courses.
Anyways , Uro recommended us BCG which is most effective treatment. I hope all goes well and result of BCG will have sufficient impact in my dad's case for cure.
I will be posting every now and then in here for updates and your advices.
Thanks to Sara, Alan as well
Regards and Respect.
From what I understand from the pathology report, the urologist is treating exactly what American Urology Association (AYA) is recommending.
"No Invasion to Lamina Propria and Deep Muscles" means that the tumor has not progressed beyond the basement membrane of epithelial cells. so, it is classified as Ta. Most patients who are diagnosed with T1 high grade which has progressed beyond the basement membrane and reached the connective tissue (Lamino Propia). So, diagnosed as Ta is a good sign.
"80% low grade, 20% high grade" - I had not seen this type of pathology report. But, it is good that the urologist went ahead with BCG treatment for TaHG rather than treating for TaLG, which is usually surveillance only without BCG. .
The urologist administered single intravesical chemotherapy within 24 hrs of the first TURBT, which should reduce the recurrence rate by 10%. This recommended by AUA. So, this is good too.
The recurrence after BCG does not necessarily have to be the removal of the bladder. If the biopsy of the new tumor is LG, there is no need to remove the bladder. I do not know how many options you have in the UAE in dealing with BCG unresponsive. Hopefully, we do not get to this point.
75 is not too old for radical cystectomy surgery in North America, especially since your dad was healthy as a horse till recently. UAE seems to have several very good hospitals, including Cleveland Clinic UAE. Again, hopefully, we do not get to this point.
I think the treatment your dad is receiving is following the AUA guideline, which seems to reflect the quality of the urologist and the care,