FDA Approves Merck's Keytruda/Chemo Combo For Early Breast Cancer

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  • The FDA has approved Merck & Co Inc MRK immunotherapy Keytruda (pembrolizumab) to treat an early form of breast cancer in combination with chemotherapy.
  • The FDA approval is for treating triple-negative breast cancer (TNBC), an aggressive form of the disease with an increased risk of recurrence.
  • KEYNOTE-522 Trial data in over 1,000 patients showed that the drug, combined with chemotherapy before surgery and then used as monotherapy after surgery, significantly prolonged event-free survival.
  • There was a 37% reduction in the risk of disease progression.
  • With this approval, Keytruda is now approved in the U.S. for 30 indications.
  • Price Action: MRK shares are up 0.08% at $77.3 during the premarket session on the last check Tuesday.
  • Related content: Benzinga's Full FDA Calendar.
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