Will Ipilimumab Get Past the FDA?

Bristol-Myers Squibb (NYSE: BMY  ) could get a double dose of good news for its melanoma treatment ipilimumab this week. Yesterday, the company announced that the drug worked in early stage melanoma patients when combined with chemotherapy. And later in the week, it's due to hear from the Food and Drug Administration about its application to treat melanoma patients that have failed previous treatment.

We haven't seen the early-stage data yet -- it'll be presented at ASCO in June -- but the trial was fairly straightforward. Patients either got ipilimumab and dacarbazine, or dacarbazine alone. The combo treatment extended survival by more than the chemotherapy alone.

The trial that supports the application for treating late-stage melanoma is a little more complicated. Bristol combined ipilimumab with an unapproved peptide vaccine called gp100, then compared the combo treatment to each single treatment. Ipilimumab by itself, and in combination with gp100, performed much better than gp100 alone. But without a true placebo control, the argument can always be made that the difference in survival was because gp100 had a negative effect on survival rather than a positive effect by ipilimumab.

The FDA didn't hold an advisory panel to review the data with a panel of outside experts, so the agency is clearly confident in its decision. The question is, in which direction? Is it perfectly fine with the gp100 control, or does it think the data is clear enough that it doesn't need experts to tell it that?

I have to think it's the former. The data is solid enough that I have a hard time seeing the agency rejecting it outright without at least listening to outside experts. And besides, even in cases like Cell Therapeutics' (Nasdaq: CTIC  ) pixantrone, where it was clear the agency was going to reject the drug, it still held an advisory panel.

Of course, something minor could always trip up ipilimumab and help drugs such as Vical's (Nasdaq: VICL  ) Allovectin-7 catch up, but I think Bristol has a good chance of getting a thumbs up this week.

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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Fool has a disclosure policy.


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  • Report this Comment On March 22, 2011, at 5:57 PM, stevenpro wrote:

    If we wanted to buy stock in Bristol Myers, we would. It cracks me up how your author's will try and post a negative comment under this stock when it moves up a little on the day. What is your all's real problem with CTIC? Maybe you own stock in BM, and your afraid CTIC will take some shareholders away, causing your stock to drop. Or, maybe I am wrong, I am sure you stick by a code of ethics, and right positive things about CTIC under Bristol Myers ticker. All you haters might affect CTIC now with your reports and have a small effect on the trade, but let their 2 drugs they have get FDA approval, and we could easily see , 2,800.00 a share days again real quick. Maybe that is your real fear.

  • Report this Comment On March 22, 2011, at 6:09 PM, stevenpro wrote:

    Amazing. I just went to BM ticker, and what do you know, no comment on CTIC. But there was however, a drop on BM stock today, and a gain on CTIC. Am I being irrational to think maybe a little biased favortism is going on? Fact of the matter is, any drug by any company that will help ANY form of fatal diseases should be welcomed and supported by the masses. But this is about money, not the complete speady recovery of the sick and dying now is it?

  • Report this Comment On March 22, 2011, at 6:44 PM, TMFBiologyFool wrote:

    stevenpro,

    No conspiracy. I was just pointing out that the FDA hated pixantrone -- clear from the briefing documents and eventual CRL -- but scheduled an advisory panel anyway. A legitimate reason to think that ipilimumab would have gotten one if the FDA hated it, no?

    We can debate the merits of their decision on pixantrone in another article. If there's a connection to something that happened to BMS, I'll be sure to include it.

    -Brian

  • Report this Comment On March 23, 2011, at 12:02 AM, stevenpro wrote:

    Fair enough Brian.

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