FDA OKs Pembrolizumab for Classical Hodgkin Lymphoma
The US Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda, Merck) for children and adults who have classical Hodgkin lymphoma (cHL) that has resisted treatment or relapsed after three or more prior lines of therapy.
A programmed death receptor-1 (PD-1) blocking antibody, pembrolizumab already is indicated for unresectable or metastatic melanoma, metastatic non-small-cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma.
The decision to extend pembrolizumab's indication to cHL was made under the FDA's accelerated approval process and based on tumor response rate as well as durability of response in a study of 210 patients, according to the drug's revised label. "Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials," the label states.
The drug was stopped in 5% of patients and interrupted in 26% because of adverse events. The most common adverse events observed in the trial included fatigue, pyrexia, cough, musculoskeletal pain, diarrhea, and rash. Serious adverse events occurred in 16% of patients, with the most common being pneumonia, pneumonitis, pyrexia, dyspnea, graft-versus-host disease (GVHD), and herpes zoster. Fifteen percent of patients had an adverse reaction that required systemic corticosteroid therapy.
The drug is administered intravenously for 30 minutes every 3 weeks until disease progression or unacceptable toxicity, according to the revised label. Patients without disease progression can take it for up to 24 months.
Merck also announced today that the FDA will take more time to review Merck's application to use pembrolizumab to treat patients with advanced microsatellite instability-high cancer who have been previously treated. The agency's new target date to act on the application is June 9.
FDA OKs Pembrolizumab for Classical Hodgkin Lymphoma. Medscape. Mar 14, 2017.
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