Merck's Keytruda Wins Eighth FDA Approval Of 2021, This Time For Adjuvant, Pediatric Melanoma Settings

The FDA has approved Merck & Co Inc's MRK Keytruda, an anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. 

• Additionally, the FDA expanded the indication for Keytruda as adjuvant treatment for stage III melanoma following complete resection to include pediatric patients (12 years and older).
• The approval is based on the first interim analysis of Phase 3 KEYNOTE-716 trial. Keytruda showed a statistically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 35% compared to placebo. 
• Median RFS was not reached for either group. After a median follow-up of 14.4 months, 11% of patients who received Keytruda had a recurrence or died compared to 17% of placebo patients. 
• See here Benzinga's Full FDA Calendar.
• Price Action: MRK shares are down 0.15% at $73.23 during Monday's last check during the premarket session.