EMA adopts positive opinion for MSD’s KEYTRUDA®

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a new extended dosing schedule for MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for all approved monotherapy indications in the European Union (EU).

In the EU, KEYTRUDA as monotherapy is currently approved for eight indications across five tumour types.

The CHMP positive opinion supports a new recommended dose of 400 mg every six weeks (Q6W) delivered as an intravenous infusion over 30 minutes for KEYTRUDA monotherapy.

If approved by the European Commission, the Q6W dose would be available in addition to the currently approved dose of KEYTRUDA 200 mg every three weeks (Q3W) infused over 30 minutes. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorisation in the EU, and a final decision is expected in the second quarter of 2019.

There are currently more than 900 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Dr Scot Ebbinghaus, vice president, clinical research, MSD Research Laboratories, said: “Importantly, the positive CHMP opinion supports the approval of a six-week dosing option across all eight approved KEYTRUDA monotherapy indications in Europe, spanning five cancer types. If approved by the European Commission, the KEYTRUDA 400 mg every six weeks dose will provide both physicians and patients with greater flexibility in their treatment plans.”