FDA approves new indication for Merck’s Keytruda

Adult patients with relapsed or refractory classical Hodgkin lymphoma now have a new treatment.

The Food and Drug Administration has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for this condition. 

Keytruda was previously approved under the FDA’s accelerated approval process for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma, or who have relapsed after three or more prior lines of therapy based on data from the KEYNOTE-087 trial.

“An estimated 8,500 patients in the United States, many of them 40 years of age or younger, will be diagnosed with cHL this year. Now patients with [classical Hodgkin lymphoma] who progress after frontline therapy have a new option in Keytruda, which has demonstrated a clinically meaningful improvement in progression-free survival compared to brentuximab vedotin,” said Vicki Goodman, Merck vice president, clinical research. “At Merck, we are committed to improving outcomes for patients with cancer. Today’s FDA approval builds upon our growing range of options for people with blood cancers.”

“The patients with cHL who do not achieve remission following initial treatment or who relapse after transplantation face a poor prognosis, reflecting the unmet need for improved therapies in the relapsed/refractory setting,” said John Kuruvilla, hematologist and associate professor of medicine, Princess Margaret Cancer Centre and the University of Toronto. “With this approval, Keytruda has the potential to change the current standard of care and help these patients achieve better outcomes.”