Posted by Michael Wonder on 18 Oct 2019
Merck receives positive EU CHMP opinion for two new regimens of Keytruda (pembrolizumab) as first-line treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma
18 October 2019 - Opinion supports use of Keytruda, as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy, in patients whose tumours express PD-L1 (CPS ≥1).
Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of two regimens of Keytruda, Merck’s anti-PD-1 therapy, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma. Keytruda, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is recommended in patients whose tumours express PD-L1 (combined positive score [CPS] ≥1).
This recommendation is based on data from the pivotal Phase 3 KEYNOTE-048 trial, in which Keytruda, as monotherapy and in combination with chemotherapy, demonstrated a significant improvement in overall survival, compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), in these patient populations.
