CHMP Supports Approval Of Merck's Keytruda As Adjuvant In Post Surgery Melanoma Setting

  • European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending Merck & Co Inc MRK Keytruda in melanoma setting.
  • The opinion covers Keytruda as a monotherapy adjuvant treatment for adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection. 
  • Additionally, the CHMP recommended expanding the indications for Keytruda in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients.
  • The positive opinion was granted based on Phase 3 KEYNOTE-716 trial results, which demonstrated a statistically significant improvement in recurrence-free survival with Keytruda compared to placebo. 
  • Earlier this year, Merck reported that KEYNOTE-716 also met its key secondary endpoint of distant metastasis-free survival. 
  • The European Commission will now review the recommendation, and a final decision is expected in Q2 or Q3 of 2022.
  • Price Action: MRK shares are up 1.08% at $93.08 during the market session on the last check Friday.
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