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/Pembrolizumab...now 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/keytruda.com
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