On this one though, I'll gently agree to disagree (as I have for a while, here). He wrote yesterday that he thinks Merck has the lead now, in a melanoma indication, with its pembrolizumab candidate (or MK-3475, if you prefer). I disagree. The race is still Nivolumab's to lose -- and so the lead is in BMS's hands. We will both find out much more in early June at ASCO, in Chicago -- but just because BMS is being old school tight-lipped, doesn't mean it has lost the lead. It is just being. . . tight-lipped. Do go read John, just the same:
. . . .Merck has landed a priority review for its top drug prospect, the PD-1 cancer drug MK-3475, giving the FDA a deadline of October 28 for making the first big marketing decision on a new wave of immuno-oncology therapies that is expected to be a game changer in the oncology market. . . .
The looming PDUFA date for MK-3475 in melanoma -- a drug that's won the FDA's breakthrough designation, promising a speedy regulatory review -- puts Merck on track to gain the first market entry in the field. . . .
I think the game really hinges on other cancers -- not just melanoma, and as I've repeatedly said -- I bet BMS reaches market with the broadest portfolio of indications, first, here. First being a six-month or more lead on others -- in the heaviest "burden of disease" cancers. I could end up being surprised at ASCO, but it would be just that -- a surprise. Word. And there will be perhaps $4 billion a year in revenue for the second to arrive here. Plenty to go around -- but first to arrive is looking like $12 billion to $16 billion -- a year. So, again, size matters.
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When and if Merck markets for melanoma only to rush it, there will be the FDA delay before going for other indications ie NSCLC. And now that vintafolide went bust the initial plans by Joe eid and co might have been revised and go for the smallest indication of the pd1 therapy while roche and bms will come out with all indications at once as the things evolve at the moment.
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