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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