
Merck Receives CHMP Positive Opinion of Keytruda (pembrolizumab) as Adjuvant Treatment for Stage IIB or IIC Melanoma
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
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