European Commission Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Adult and Pediatric Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients aged 3 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. This approval is based on results from the pivotal Phase 3 KEYNOTE-204 trial, in which KEYTRUDA monotherapy demonstrated a significant improvement in progression-free survival (PFS) compared with brentuximab vedotin (BV), a commonly used treatment. KEYTRUDA reduced the risk of disease progression or death by 35%.