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ARTICLE | Regulation

Keytruda’s master class in accelerated approval

Merck’s Keytruda land grab has relied on strategic use of accelerated approval pathway

August 30, 2021 1:03 PM UTC

PD-1 inhibitor Keytruda towers above other graduates of FDA’s accelerated approval pathway, with 34 accelerated approvals under its belt, of which 18 are for different indications and 16 for new dosing. Second after Keytruda is Opdivo nivolumab, with 11 accelerated approvals as of June 30.

Keytruda has set an example for how companies can use accelerated approval to rapidly gain market dominance. The pattern of its trials tells the story of how Merck is going about confirming benefit and maintaining marketing authorization...



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