The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of an expanded label for Keytruda (pembrolizumab).
The opinion is recommending Keytruda as monotherapy for the treatment of adult and pediatric patients aged three years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant or following at least two prior therapies when ASCT is not a treatment option.
Keytruda is sponsored by Merck.
This recommendation is based on results from the pivotal phase III KEYNOTE-204 trial, in which Keytruda monotherapy demonstrated a significant improvement in progression-free survival compared with brentuximab vedotin, a commonly used treatment.
Keytruda reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88]; p=0.00271) and showed a median PFS of 13.2 months versus 8.3 months for patients treated with BV.
The recommendation is also based on supportive data from an updated analysis of the KEYNOTE-087 trial, which supported the European Commission’s approval of KEYTRUDA for the treatment of adult patients with relapsed or refractory cHL who have failed ASCT and BV or who are transplant ineligible and have failed BV.
The CHMP’s recommendation will now be reviewed by the EC for marketing authorization in the European Union, and a final decision is expected in the first quarter of 2021. If approved, this will be the first pediatric indication for Keytruda in the EU.