FDA approves Merck’s Keytruda with Gilead’s Trodelvy for first-line PD-L1+ advanced TNBC

Merck & Co., Inc.
Gilead Sciences, Inc.

Merck & Co., Inc.

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Gilead Sciences, Inc.

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  • FDA cleared Merck’s Keytruda or Keytruda Qlex with Gilead’s Trodelvy for first-line PD-L1+ (CPS ≥10) advanced triple-negative breast cancer.
  • Decision based on KEYNOTE-D19/ASCENT-04, showing 35% lower progression or death risk; median PFS 11.2 months vs 7.8 months.


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