First approval for Keytruda in a hematologic malignancy in the EU

European Commission approves Keytruda for patients with relapsed or refractory classical Hodgkin lymphoma who failed ASCT and BV or who are transplant-ineligible and have failed BV.

Merck (MSD) has announced that the European Commission has approved Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV. The approval allows marketing of Keytruda in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every 3 weeks until disease progression or unacceptable toxicity.

"Today’s approval brings an important new treatment option to patients in Europe with classical Hodgkin lymphoma who have not responded to existing therapies," said Dr Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. "This milestone underscores our commitment to evaluating Keytruda in diseases with unmet need facing the hematology community."

"For patients with classical Hodgkin lymphoma who have not been successfully treated with prior therapies – many of whom are young and have a poor prognosis – there are limited options and treating the disease poses significant challenges," said Pier Luigi Zinzani, associate professor of hematology, Institute of Hematology "L. e A. Seràgnoli," University of Bologna. "With this approval, we will now be able to provide these patients with a much needed new treatment option."