EU Panel Backs Extended Pembrolizumab Dosing Schedule for Single-Agent Indications

March 4, 2019 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a new extended dosing schedule for pembrolizumab for all of the PD-1 inhibitor’s monotherapy indications in the European Union. The recommendation supports a new suggested dose of single-agent pembrolizumab at 400 mg every 6 weeks delivered as an intravenous (IV) infusion over 30 minutes. If approved by … (leggi tutto)