RE:LabelXiamen,
Myocyclin is an antiobiotic. It is use/used to treat infections. In fact, according to new studies, bladder cancer could be a side effect of taking myocyclin. From what I read, it's of no use to treat NMIBC patients. Please give us a link if you have something on this.
Back to your question. True that question 3a was quickly discussed (page 200 of the transcript). Only Dr Agarwal (one of the three urologists who voted yes) was listed as a discussant for that specific question. He did say that 1) biologically the absence of CIS (from MCNA therapy) is more convincing than in the setting of papillary tumors and 2) that the degree of benefit is greater that what was seen in the Valrubicin study. But regarding question 3b (papillary only tumors) he also went on to say that he doesn't think (from urologists' experience) that you can treat papillary disease without combining resection with an intravesical treatment. Implying that MCNA should also be approved for papillary only tumors.
You can also find comments from no voters in the afternoon saying that CIS / relapsing. See Dr Pavlovich (the only urologist who voted no) comment at page 208. Dr Pavlovich seemed to have a psychological upper hand on other members of the panel during the adcom meeting and from start you could tell he had problem with the ("large") indication chose by TST. But even there he kind of admitted that MCNA might have a role in patients with CIS-containing bladder cancer (refractory and relapsing).
I think not much was said during question 3a discussion simply because not much had to. From their own briefing document, the FDA clearly see a favorable benefit-risk ratio for that CIS subpopulation. They would'nt have so as far as explaining that a "mitigation plan would be needed to mitigate the concern that delaying cystectomy could increase the risk of development of MIBC / metastatic BC. That being said, I thought question 3b was going to bring a deeper discussion. But the reality is at the 2013 FDA BC workshop, experts did not even agree on how to include papillary only tumors in NMIBC trials.
Anyway here are my personal interpretation of things at this point, in term of % chance of approval for the different indications :
1) CIS-contaning disease patients who failed BCG that can't or won't undergo cystectomy : 70 %
2) NMIBC patients at high risk who failed BCG that can't or won't undergo cystectomy : 25 %
3) NMIBC patients at high risk who failed BCG (original indication) : 5 %
TST still has realistic chance for the # 2 scenario giving the fact that at least 10 experts (40 % of the group) said yes for that indication...among them the majority of the practicing urologists (3 out of 4) and the chairperson at the adcom. I'm hoping the FDA will give more importance to these 4 "yes" votes than to the ODAC "no voters" that should have hit the third button...like Hightea said.
M80