Like BMS Before It, Merck Announces A Slowed FDA Timeline In One Anti PD-1 Melanoma Indication, And Acceleration, In Another

About a week ago, BMS announced that its targeted complete response date from FDA had been pushed into November 2015 on an Opdivo® label expansion into other melanoma indications. This morning Merck has done much the same, and this time, in first line melanoma treatments.

Also like BMS, FDA has accepted for priority review Merck’s submission in melanoma with differing treatment precursors. Sort of a good news, and delay news — as a two for one — echoing BMS of a few weeks past. Here’s the bit from StreetInsider:

. . . .The FDA granted Priority Review with a PDUFA, or target action, date of December 19, 2015. Additionally, the FDA has extended the action date for a separate sBLA for KEYTRUDA for the treatment of patients with ipilimumab-refractory advanced melanoma. The new action date is now December 24, 2015. . . .

I might suggest, without looking into it too deeply, that FDA suspects BMS will have better efficacy here in the delayed indication — thus the November 2015 date for Opdivo, compared to a December date for Keytruda. I’ll trust the readership to correct me if I am mistaken about that. Smile. . .

My overall assessment is unchanged. BMS has a clear timing lead. Having said that, the overall market opportunity is so vast, that Merck will generate multiple billions in new reveue here, as well, going into mid-2017 (even as the payers seek limits on price). So, onward — out into a hot likely rain soaked August workaday world — but it is teeming with possibilities, as well. . .


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