Pier Luigi Zinzani, MD, PhD
The FDA has granted a priority review to a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as a treatment for adult and pediatric patients with relapsed/refractory primary mediastinal large B-cell lymphoma (PMBCL).
Merck, the manufacturer of pembrolizumab, issued a press release announcing the agency's decision on December 11, 2017. The FDA reviewed the sBLA based on results from a cohort of the phase II KEYNOTE-170 trial evaluating the anti–PD-1 agent in 29 patients with PMBCL. The findings were first presented at the 14th International Conference on Malignant Lymphoma and updated data were recently presented at the 2017 ASH Annual Meeting.
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