Merck Melanoma Candidate Granted “Breakthrough” Designation At FDA — But BMS’s Nivolumab Is Out Ahead, On Timelines

Make no mistake, this morning’s “ultra” fast-track designation at FDA is good news for Whitehouse Station. And MK-3275, or C6504H10004N1716O2036S46, if you prefer (a honkin’ big human G4 peptide, that!) is a great oncology candidate, based primarily on some smallish study results.

It will be chasing Bristol Myers Squibb’s Nivolumab, though — and playing the catch-up game, from here forward, in my estimation.

Either one could still run into late-breaking unforeseen difficulties, changing all of this — but at the moment the lead looks to belong to BMS. It is theirs to lose — Nivolumab should reach market first, in this class. That’s my guess. Even so, good news at Merck — and good for the FDA’s reputation — as it tries to act collaboratively — but still with a vigilant eye on safety — for truly novel candidates. Life saving candidates — like these.

A bit from the MarketWatch story, via a hat-tip to my buddy, Ed Silverman, at Pharmalot — do go read it all.

. . . .The Merck drug is an antibody designed to help the body’s immune system go after cancer cells. Lambrolizumab, also known as MK-3475, specifically targets the “programmed death” 1 receptor, or PD-1, which cancer cells can exploit to escape destruction by the immune system. Bristol-Myers Squibb Co. also is developing an anti-PD-1 drug, nivolumab, that is in Phase 3 testing.

In November, Merck said about half of patients in a Phase 1 study for whom results were available at that time experienced tumor shrinkage after treatment with lambrolizumab and about 10% had no detectable cancer after treatment as assessed by imaging techniques.

Some patients experienced adverse events including fatigue, rash and diarrhea. Some adverse events were believed to be related to the drug’s mechanism of action of unleashing the body’s immune system.

Merck also is studying the drug as a potential treatment for non-small cell lung cancer. . . .

Probably not ever to rise to the level of a blockbuster, for Whitehouse Station, but we will keep you posted, just the same.

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