About Seven Months Behind BMS, Merck Likely To Receive A Preliminary Nod, For NSCLC FDA Label Expansion Tonight

MRK-Key-NSCLC-10-2015 UPDATED: The full Commission just granted immediate approval — so Keytruda® is now authorized for NSCLC. End, update.

Just as we predicted, Merck is now about seven (per our cogent and erstwhile anonymous commenter — thanks!) nine months behind BMS’s Opdivo®, in reaching approval for Keytruda, in the heavy burden of disease lung cancers. If all goes well, this afternoon, Merck will be on market, on Monday is about a month from market.

Assuming that FDA follows its normal course, and the staff recommends the accelerated approval to the full FDA Commission, after the close of trading on the NYSE today, we should see an that an approval (label expansion, actually) is granted to Keytruda, for NSCLC, after non-response to platinum chemotherapy. in about a month. [My math was off, by one — and the immediate full FDA approval cut a month from the lead, as well.] Should it materialize tonight, it will be good news for Merck, and will allow Kenilworth to beging to directly market the humanized monoclonal antibody to oncologists treating lung cancer patients, rather than relying on those oncologists to be willing to write “off label”. I do expect that a fair amount of completely appropriate direct and independent “off label” scrip writing was already underway, by oncologists around the nation. In any event — welcome news for Merck and its lately sagging NYSE stock price.

[Separately, I highly recommend catching “The Martian” this weekend — I did, late last night — and it was a great human interest treat; the sci-fi and amazing effects were. . . just a bonus. Onward!]

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