Thursday, September 4, 2014

Merck's anti-PD1 drug gets FDA approval!!!

It's true.  FDA approval granted to Merck's anti-PD1 drug - MK-3475/ to be marketed as Keytruda.  Here's a link from TheStreet, The Wall Street Journal, and OncLive:

MK3475/Pembrolizumab/Keytruda is FDA approved

fda-approves-mercks-cancer-drug- article by Peter Loftis of Wall Street Journal

FDA-Approves-Pembrolizumab-for-Advanced-Melanoma - OncLive

The gist:  A Merck spokesperson reports that Keytruda will cost $12,500.00 per month - $150,000.00 for a year of treatment.  "It was approved for people who've failed to respond adequately to Yervoy (ipi)."  Failure of a BRAF inhibitor in BRAF positive patients will be required as well.  The BMS anti-PD1 product, Nivolumab, was approved in Japan under the name of Opdivo earlier this year.  BMS is expected to file by September 30 for FDA approval of Nivo as a treatment for melanoma and to file by year's end for its approval as a treatment for lung cancer here in the United States.

Dosage per package insert:  2mg/kg infused every three weeks until disease progression or unacceptable toxicity.

Scuttlebutt, so I'm not sure of the total accuracy here:  EAP centers will close and transition to commercial insurance with a transition team. If unable to pay, there will be assistance through: http://www.merckaccessprogram/

Clearly, a very good start for many folks.  I am disappointed about the requirement to have failed ipi and BRAFi, for the BRAF positive, beforehand and fear the cost of treatment will become a barrier for many.  But, a big step in the right direction!!!

Here's to all the ratties who made it happen!!! - c

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