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 (NYSE: 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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