New York, NY (June 13, 2018) –The U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.
The approval is based on data from a clinical trial evaluating pembrolizumab in patients with relapsed or refractory PMBCL. The FDA noted in its approval statement that the agency does not recommend pembrolizumab for patients with PMBCL who require urgent cytoreductive therapy. The accelerated approval for pembrolizumab in this setting is contingent on the results of a confirmatory trial.
“This accelerated approval of pembrolizumab offers patients with relapsed or refractory primary mediastinal large B-cell lymphoma a new treatment option and new hope for improving patient outcomes,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “We applaud the FDA, Merck and the patients who participated in the clinical trials for their roles in advancing treatment options for people living with PMBCL.”
Diffuse large B-cell lymphoma is the most common form of non-Hodgkin lymphoma (NHL), accounting for about 22 percent of newly diagnosed cases of B-cell NHL in the United States.