Merck Receives CHMP Positive Opinion of Keytruda (pembrolizumab) as Adjuvant Treatment for Stage IIB or IIC Melanoma
- 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
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at firstname.lastname@example.org.