Tuesday, March 14, 2017

Just Announced: New FDA Action Date For Keytruda® sBLA -- In MSI-H Cancers -- Now June 9, 2017 (Was March 8, 2017)

Kenilworth just provided some additional local color, on when we might next hear of an FDA action (thumbs up or thumbs down) on pembrolizumab, in these previously treated oncology co-horts.

Here's a bit of the press release -- but all of this news is almost certainly factored-in to Merck's NYSE trading price, already -- in my estimation -- just as we discussed it, late last Friday.

. . . .Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for previously treated patients with advanced microsatellite instability-high (MSI-H) cancer. The company recently submitted additional data and analyses to the FDA related to the pending application. The submission of additional data is considered a major amendment to the sBLA under the Prescription Drug User Fee Act (PDUFA), thus extending the target action date by three months. The new FDA target action date is June 9, 2017.

Merck continues to work closely with the FDA to support the review of this sBLA and looks forward to further advancing the science of immuno-oncology in MSI-H cancer. . . .

Now, as to air traffic control, I'm on a short day in the office tomorrow, then on various planes through the weekend. Even so, do get in touch. . . .


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