So — while the potential October 28 date at FDA for Merck’s immuno-Anti-PD-1 candidate remains in place (and likely ahead of BMS’s timeline in the US — for melanoma), BMS is swiftly pivoting toward approvals in the US for lung cancer — the bigger market opportunity, by far – and is very likely to garner the first US FDA approval, for that mammoth indication. To speak more plainly, that will render Merck’s candidate quite clearly. . . a second-class citizen, in the most important market, I’m afraid.
This bears much more close watching — but it seems the horse race is now BMS’s to lose. It has the most important lead, here. From Investors’ Business Daily, then:
. . . .Nivolumab, now branded Opdivo, is Bristol’s lead drug in the much-anticipated anti-PD-1 class of cancer fighters and has achieved outstanding results in clinical trials against melanoma when combined with Bristol’s already-launched drug Yervoy. . . .
[ISI's Mark] Schoenebaum added that the combo will probably become the standard of care and overtake Merck’s anti-PD-1 pembrolizumab, which is in process for a melanoma approval perhaps eight months ahead of Opdivo’s. Opdivo is also already on the FDA’s agenda as a treatment for squamous-cell lung cancer and was approved for melanoma three days ago in Japan. . . .
So — if Merck reaches US FDA approval in melanoma first (though as of this morning, there isn’t even an Advisory Committee date on the FDA’s official calendar — for immuno-oncology candidates) — it will likely only be by a few months, as I’ve long held. The bulk of this perhaps $35 billion market opportunity will go to BMS. Just my guess. Do stay tuned.