On June 15, 2023 the U.S. Food and Drug Administration (FDA) announced it has approved glofitamab-gxbm (Columvi, Genentech, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. “People with relapsed or…
On 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. “The…
On 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),…
On April 6, 2023, AbbVie announced its intent to withdraw the accelerated approval of ibrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and with marginal zone lymphoma (MZL) who…
On January 27, 2023 the U.S. Food and Drug Administration (FDA) announced it has approved pirtobrutinib (Jaypirca, Eli Lilly and Company), for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.…
On January 19, the U.S. Food and Drug Administration (FDA) announced it has approved bruton tyrosine kinase (BTK), zanubrutinib (Brukinsa, BeiGene), for chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL). BTK is a protein critical for the growth and survival of B-cells. BTK…
On December 22, 2022, the U.S. Food and Drug Administration (FDA) announced it has approved the use of mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), a bispecific antibody, for the treatment of adult patients with relapsed/refractory follicular lymphoma (FL) after two or more…
The U.S. Food and Drug Administration Approves Lisocabtagene Maraleucel (Breyanzi) for Large B-Cell Lymphoma On June 24, 2022, the U.S. Food and Drug Administration (FDA) announced it has approved the use of lisocabtagene maraleucel (liso-cel, Breyanzi), a chimeric antigen receptor…