Modeling Is Not a Drug Approval Pathway: Why Merck Flunked Keytruda’s TNBC Advisory Panel

Advisory panel agrees with US FDA that Merck’s pathological complete response data is not strong enough for accelerated approval in high-risk, early-stage triple-negative breast cancer patients and says modeling of expected outcomes data cannot make up for this weakness.

photo illustration/shutterstock
Keytruda may have a long road ahead for its next approval after a stop at ODAC. • Source: photo illustration/Shutterstock

The US Food and Drug Administration’s Oncologic Drugs Advisory Committee voted unanimously in favor of delaying an approval decision on Merck & Co., Inc.’s Keytruda (pembrolizumab) for treatment of high-risk, early-stage triple-negative breast cancer, siding with the agency’s position that modeling cannot substitute for completed clinical trial data.

The 10-0 panel vote on 9 February was also a reminder of the limits FDA has laid out around the...

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