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John H. Ford , Contributor
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Author?s reply » I spent the last 3 days reading and researching 175 pages of briefing documents, and listening to yesterday?s advisory committee meeting, and given all the information, I was surprised at the outcome. The entire vote was based on this question:
Does MCNA have an overall favorable benefit risk profile for the treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who failed prior BCG immunotherapy, e.g. in patients who are BCG refractory or BCG relapsing?
According to the FDA analysis, the primary endpoint of DFS 1y was 20.9%. The safety profile was stellar. With that data in mind the obvious answer to the above question is yes. But the advisory committee voted no primarily because panelists questions about the trial and data were not adequately answered.
Many of the doctors who voted no made it clear that they almost voted yes, but didn?t quite feel comfortable with the presented information.
What?s encouraging is that of the urologists on the panel, the majority voted yes. This is a needed drug that urologists want. There was only one patient on the panel, and he voted yes also. If the panel would have contained only urologists and patients, I believe the overall vote would have been yes.
I am disappointed in the outcome, because if the FDA does not approve in February, patients will have to wait for another trial to be conducted before having access to this drug. In my opinion the advisory committee ignored the big picture, and if the benefit risk question would have been answered literally, a unanimous yes would be the only reasonable outcome. From all the data I saw, the benefit outweighs the risk.
The FDA will be basing its decision in February on the following question:
"If the FDA decides that the benefits of a drug outweigh the known risks, the drug will receive approval and can be marketed in the United States."
Since the benefits appear to outweigh the risks, the FDA should approve the drug. However, given the advisory committees negative vote, the drug may not be approved.
It?s interesting that Valstar went through the same issue with the advisory committee. The advisory committee did not recommend approval, and yet the FDA went on to approve Valstar, going against the advisory committee?s recommendation. The objections the advisory committee had to Valstar are almost identical to the objections raised against Telesta?s drug. Here is the summary from the press release:
The Oncologic Drugs Advisory Committee of the US FDA has failed to recommend approval of Anthra's valrubicin (AD 32, VALSTAR) for the treatment of refractory bladder carcinoma in situ. The committee reportedly considered that the open label studies conducted by the company were not rigorous enough and that without a controlled trial it is difficult to assess whether delayed cystectomy will result in an increase in bladder cancer. According to results presented to the FDA by Anthra, valrubicin treatment delayed cystectomy by 8.3 months in nonresponders and 23 months in responders. Anthra had reported that 22% of patients had a complete response, but upon reanalysis of the data, the FDA found only 8% of patients had experienced a complete response. ?
I have no idea what the FDA will do in February, I can only hope it will give patients access to MCNA. The FDA is generally reasonable, and understands the level of need.
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