Diffuse Large B-Cell Lymphoma: FDA Updates

June 15, 2023 – The U.S. Food and Drug Administration (FDA) announced it has granted accelerated approval to glofitamab-gxbm (Columvi, Genentech, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. More information.

May 19, 2023 – The U.S. Food and Drug Administration (FDA) announced it has approved epcoritamab-bysp (Epkinly, co-developed by Genmab and AbbVie) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. More information.

April 19, 2023 – The U.S. Food and Drug Administration (FDA) announced it has approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.) with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of 2 or greater. More information.

April 1, 2022 – The U.S. Food and Drug Administration (FDA) announced it has approved axicabtagene ciloeucel (YESCARTA, Kite, a Gilead Company), a chimeric antigen receptor (CAR) T cell therapy, for adult patients with certain types of diffuse large B-cell lymphoma (DLBCL) who is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. More information.

December 2, 2021 – The U.S. Food and Drug Administration (FDA) announced it has approved rituximab (RITUXAN, Genentech, Inc.), a monoclonal antibody, in combination with chemotherapy for pediatric patients aged at least 6 months to 18 years with previously untreated, advanced staged, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), and Burkitt-like lymphoma (BLL). More information.

April 23, 2021 – The U.S. Food and Drug Administration (FDA) announced it has approved loncastuximab tesirine-lpyl (ZYNLONTA, ADC Therapeutics), a CD-19-directed antibody and alkylation agent conjugate, for 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) no otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.

February 8, 2021 – The U.S. Food and Drug Administration (FDA) approved the use of the chimeric antigen receptor (CAR) T cell therapy lisocabtagene maraleucel (liso-cel, Breyanzi) for the treatment of adult patients with certain types of large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have not responded to, or who have relapsed after, at least two other types of systemic treatment. Liso-cel, is the fourth CAR T cell therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL).

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.