European Commission approves licence extension for pembrolizumab as monotherapy for treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma (cHL)

Approval is for use in patients who have failed autologous stem cell transplant (ASCT) or following ≥2 prior therapies when ASCT is not treatment option, and is based on results from Phase 3 KEYNOTE-204 trial showing improvement in progression free survival vs brentuximab vedotin

SPS commentary:

This approval is the first paediatric approval for pembrolizumab in the European Union and is also based on supportive data from updated analysis of KEYNOTE-087 trial, which was basis for 2017 EC approval of pembrolizumab for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed ASCT and brentuximab vedotin (BV) or who are transplant ineligible and have failed BV.

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