Expanded Keytruda indication in EU and first for pediatric patients

The European Commission (EC) has approved an expanded label for Keytruda (pembrolizumab) as monotherapy for adults and children aged three years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option.

Merck & Co’s (NYSE: MRK) anti-PD-1 therapy won the approval partly based on results from the pivotal Phase III KEYNOTE-204 trial, in which Keytruda monotherapy demonstrated a significant improvement in progression-free survival (PFS) compared with brentuximab vedotin.

"The EC’s approval of an expanded use of Keytruda provides another option for adult and pediatric patients with cHL who have disease progression after earlier lines of therapy or relapse after transplantation"Keytruda reduced the risk of disease progression or death by 35% and showed a median PFS of 13.2 months versus 8.3 months for patients treated with brentuximab vedotin, which is marketed by Takeda (TYO: 4502) and Seattle Genetics (Nasdaq: SGEN) as Adcetris.