Tuesday, February 20, 2024

Merck Wins FDA Priority Review In Certain Uterine Cancers, For Keytruda®, Plus Chemo-... Good News.


This is decidedly good news, but given that pembrolizumab already generates over $25 billion a year in revenue. . . in the near term, this coming approval will not materially boost that total -- all by itself.

But this certainly continues the impressive winning streak -- against a wide array of solid organ tumors / cancers, where Keytruda® is now greatly extending survival odds, and quality of life durations. Here's the latest, from a Merck presser this morning:

. . .[Rahway] announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel), followed by KEYTRUDA as a single agent for the treatment of patients with primary advanced or recurrent endometrial carcinoma.

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024. . . .


Onward, into the warm sunshine now -- grinning. Be excellent to one another.

नमस्ते

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