Materially Good Keytruda® News: Merck To Pivot Keynote-001 Data, For NSCLC Priority Clearance At FDA

Much as BMS did, with its April 2015 NSCLC (lung cancer) priority review and FDA approval, Merck’s regulatory and science teams have done an excellent job in study design, and coordinated preparation, to reach this moment.

Lung cancers are the most threatening, in terms of burden of disease, class of cancers — in the United States. Said another way, this is the gold miners’ mother lode. Kenilworth has shown its new tools, and mettle, here. Kudos.

Merck may hear by early October 2015, if all runs “according to Hoyle“, that it may formally begin to charge for the therapy in lung cancer patients who are not seeing improvement on standard platinum chemotherapy. I say charge for it, because early compassionate access programs, as well as study protocols, mean that many lung cancer patients are already on the immuno-oncology candidate. So, if all goes well, Merck will only be about eight to nine months behind Opdivo®, in starting its own revenue ramp. [Both are already selling to melanoma.] This is certainly a vast market — and unmet need. A bit from the press wires, overnight, then:

. . . .Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. The FDA granted Priority Review with a PDUFA, or target action, date of October 2, 2015; the sBLA will be reviewed under the FDA’s Accelerated Approval program. . . .

The sBLA submission was based in part on data from KEYNOTE-001 – including patients with greater than or equal to 50 percent of tumor cells positive for PD-L1 expression – which were presented at the 2015 American Association for Cancer Research (AACR) Annual Meeting. These data also served as the basis for the FDA Breakthrough Therapy designation for KEYTRUDA in advanced NSCLC. . . .

And so, for all of those relationships — and people — we’ve lost, we do give thanks, for the time that was. . . . For so many, this exciting moment has arrived too late — and I speak not only of the patients claimed to cancers.


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