Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and new indications for older therapeutic agents used in hematologic oncology.
Glofitamab for DLBCL
On June 15, 2023, the FDA granted accelerated approval to glofitamab-gxbm (Columvi) for relapsed or refractory diffuse large B-cell lymphoma–not otherwise specified (DLBCL-NOS) or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy.
Epcoritamab for DLBCL
On May 19, 2023, the FDA granted accelerated approval to epcoritamab-bysp (Epkinly) for relapsed or refractory DLBCL-NOS, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
Polatuzumab Vedotin for DLBCL
On April 19, 2023, the FDA approved polatuzumab vedotin-piiq (Polivy) with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated DLBCL-NOS or high-grade B-cell lymphoma and who have an International Prognostic Index score of 2 or greater.
Pirtobrutinib for Relapsed/Refractory Mantle Cell Lymphoma
On January 27, 2023, the FDA granted accelerated approval to pirtobrutinib (Jaypirca) for relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a BTK inhibitor.
Zanubrutinib for CLL/SLL
On January 19, 2023, the FDA approved zanubrutinib (Brukinsa) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Mosunetuzumab for Relapsed/Refractory Follicular Lymphoma
On December 22, 2022, the FDA granted accelerated approval to mosunetuzumab-axgb (Lunsumio) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Olutasidenib for Relapsed/Refractory AML
On December 1, 2022, the FDA approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
Brentuximab Vedotin for Pediatric Hodgkin Lymphoma
On November 10, 2022, the FDA approved brentuximab vedotin (Adcetris) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high-risk classical Hodgkin lymphoma.
Teclistamab for Relapsed/Refractory Multiple Myeloma
On October 25, 2022, the FDA granted accelerated approval to teclistamab-cqyv (Tecvayli) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Pemigatinib for Relapsed/Refractory Myeloid/Lymphoid Neoplasms
On August 26, 2022, the FDA approved pemigatinib (Pemazyre) for adults with relapsed or refractory myeloid/lymphoid neoplasms with fibroblast growth factor receptor 1 (FGFR1) rearrangement.