Wednesday, September 7, 2016

Good News For Kenilworth: Keytruda® (Pembrolizumab) "Fast Tracked" At FDA -- First Line NSCLC Approval By Christmas Eve 2016?

Ahem. First, a little bit of sobering perspective -- before the morning's marketing sizzle: Since March of 2015 -- or going on nearly 18 months, now -- BMS and Opdivo® (nivolumab) has held an FDA approval in second line NSCLC -- that is, after a try at chemo. I strongly suspect that oncologists are essentially writing off-label -- with both Opdivo, and Keytruda® -- administering it at least to private-pay patients, as essentially a first line therapy/treatment.

I do not expect that will change. BMS estimates that 15 per cent of its sales in immuno-oncology come via off-label uses. Even so, this is clearly good news for Merck, as it opens (for example) the VA health system covered lives to reimbursement, by Christmas Eve this year -- if FDA sticks to its accelerated review schedule. As I've long said, BMS will also win first line approval in NSCLC, though that may come mid-2017. Thus far, Roche's Tecentriq® hasn't made a dent here -- but this will be a vast market-place, with billions of annual revenue for each of the three competitors.

Here is a bit of the NASDAQ version of the press release of earlier this morning:

. . . .The FDA granted Keytruda, or pembrolizumab, breakthrough therapy designation and priority-review status with a target action date of Dec. 24.

Merck's latest submissions were based on data from a pivotal phase 3 Keynote-024 study released in June, which showed that Keytruda monotherapy resulted in superior progression-free survival as well as overall survival compared with standard chemotherapy. The trial was stopped early so patients still on chemotherapy could opt to start treatment with Keytruda. . . .

We will of course keep an eye on these deadlines. Christmas Eve 2016 -- seems poetic, and prophetic. And so it is, that many a good thing arrives in small book sized Fex Ex pouches. Or at least I think they do. . . . Smile. . .


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