Posted by Michael Wonder on 01 Feb 2021
Merck receives positive EU CHMP opinion for expanded approval of Keytruda (pembrolizumab) in certain patients with relapsed or refractory classical Hodgkin lymphoma
1 February 2021 - Opinion granted based on significant progression-free survival benefit demonstrated with Keytruda monotherapy compared to brentuximab vedotin in pivotal Phase 3 KEYNOTE-204 trial.
Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of an expanded label for Keytruda, Merck’s anti-PD-1 therapy.
The opinion is recommending Keytruda as monotherapy for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.
