The FDA Approved Pembrolizumab for Another Indication

Severe side effects occurred in 16% of patients with the common ones including pneumonia, fever,
dyspnea, graft-versus-host disease (GVHD) and herpes zoster.
Two patients died due to disease progression. One died of GVHD after allotransplant, and the
other died of septic shock.
Summary
KEYNOTE-087 indicates that Pembrolizumab is effective in treating most recurrent or resistant
Classical Hodgkin lymphoma.
Craig, professor of Memorial Sloan-Kettering Cancer Center, and Roger, professor of Merck
Research Laboratories commented on this study.
Professor Roger said that Pembrolizumab's approval today showed that immune checkpoint
inhibitors might have potential to be used widely in many cancers.
As for children, Pembrolizumab has limited data on the treatment of children with Hodgkin's
lymphoma and its validity is based on an exploration of adult trials.
Safety considerations for pediatric use are based on a mixed study of 40 advanced, PD-L1-positive
advanced melanomas, recurrent or refractory solid tumors or lymphoma.
Drug safety is similar for both adults and children. Among children, the incidence of side effects
increased by about 15%, which mainly include fatigue, nausea, abdominal pain, hyperlipidemia,
hyponatremia and so on.
Professor Craig pointed out that CHLs which cannot be treated with existing therapies offer
particularly limited choices and great challenges for patients. Pembrolizumab's approval gave
CHL patients a chance. After all, most of these patients are very young, while the prognosis is still
poor. Therefore, they need such disease-resistant weapon.