Diffuse Large B-Cell Lymphoma: FDA Updates

July 31, 2020 – The U.S. Food and Drug Administration (FDA) announced it has approved tafasitamab-cxix (MONJUVI), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide (REVLIMID) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant. More information.

June 22, 2020 – The U.S. Food and Drug Administration (FDA) approved selinexor (XPOVIO) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma (FL), after at least 2 lines of systemic therapy. More Information.

June 10, 2019 – The U.S. Food and Drug Administration (FDA) approved polutuzumab vedotin-piiq (Polivy) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after at least two prior therapies.  More Information.

June 13, 2018 – The U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of adult patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or those who have relapsed after two or more prior lines of therapy. More Information.

May 1, 2018 – The U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah), a cell-based gene therapy, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. More Information.

October 18, 2017 – The U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).  More Information.

August 2, 2017 – The U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD. More Information.

June 22, 2017 – The U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (RITUXAN HYCELA, Genentech Inc.) for adult patients with previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. More Information.