Merck: CHMP approves keytruda

(CercleFinance.com) - Merck has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Keytruda in combination with chemotherapy, and then as adjuvant therapy, after surgery in people with early-stage locally advanced or triple-negative breast cancer (TNBC) who are rat high risk of relapse.


A phase III trial showed that after a median follow-up of 39 months, the Keytruda combination regimen with chemotherapy followed by adjuvant monotherapy with Keytruda reduced the risk of events or death by 37% compared to the chemotherapy-placebo regimen.

Merck is now awaiting the European Commission's decision on whether to grant marketing authorisation for Keytruda in this indication. The final decision is expected in the second quarter of 2022.


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