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A look back at all the FDA news that happened in the month of May 2019, including several new approvals, orphan drug designations, breakthrough therapy designations, fast track designations, and more.

Combining lenalidomide with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone did not improve progression-free survival compared with placebo and R-CHOP as a frontline therapy in patients with activated B-cell-type diffuse large B-cell lymphoma, missing the primary endpoint of the phase III ROBUST trial.

A novel Fc-enhanced CD19-targeted antibody, MOR208, is generating interest for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for high-dose chemotherapy and autologous stem cell transplantation and is making its way toward a future regulatory filing.

Researchers have defined a clinically and biologically distinct subgroup of tumors within germinal center B-cell&ndash;like diffuse large B-cell lymphoma characterized by a gene expression signature of high-grade B-cell lymphoma with&nbsp;<em>MYC&nbsp;</em>and&nbsp;<em>BCL2&nbsp;</em>and/or&nbsp;<em>BCL6&nbsp;</em>rearrangements, according to a study published in the&nbsp;<em>Journal of Clinical Oncology</em>.