Monday, June 30, 2014

With BMS's Nivolumab Right Behind It, Merck Has Filed MK-3475 (Pembrolizumab) With The EMA: On Melanoma

Well, the Anti PD-1 ultra-marathon race is starting to get very interesting -- on the EU regulatory approvals front.

I still think BMS will see approval very shortly after Merck, in melanoma -- but Merck may have a month or two lead on BMS in Europe -- and maybe a little more, here in the US, at least on a melanoma indication. From PharmiWeb, then:

. . . .[Merck] today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for pembrolizumab (MK-3475) the company’s investigational anti-PD-1 antibody for the treatment of advanced melanoma. If approved by the European Commission (EC) pembrolizumab has the potential to be the first anti-PD-1 therapy in Europe. Additional regulatory filings in other countries outside of Europe are planned by the end of 2014. . . .

Do stay tuned (this will be a multi-faceted, multi-indication ultra marathon, run in at least six stages) -- and we will dip in and out during the shortened week, here. Have a safe and restful holiday week, one and all. Be excellent to one another.

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