Shots:

• The EMA’s CHMP has adopted a positive opinion recommending approval of Keytruda as monothx. for the adjuvant treatment of adults and adolescents aged ≥12yrs. with stage IIB or IIC melanoma and who have undergone complete resection
• The opinion was based on the P-III (KEYNOTE-716) trial evaluating Keytruda (200mg or the pediatric dose 2mg/kg, IV, q3w, for ~1yr.)  vs PBO in 976 patients aged ≥12yrs. with resected stage IIB or IIC melanoma. The results showed a significant improvement in RFS and distant metastasis-free survival
• Additionally, the EC will review the CHMP’s recommendation for the marketing authorization of Keytruda in the EU with an expected final EC decision in Q2’22 & Q3’22

Ref: Merck| Image: Merck