Hematologic Malignancies
On August 14, 2023, the FDA accelerated the approval of elranatamab-bcmm (Elrexfio; Pfizer), a bispecific B-cell maturation antigen–directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 previous lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Read More ›
On August 9, 2023, the FDA accelerated the approval of talquetamab-tgvs (Talvey; Janssen Biotech), a bispecific GPRC5D-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Read More ›
Chicago, IL—Interim results from the phase 3 COMMANDS trial demonstrated that first-line treatment with luspatercept-aamt (Reblozyl) increased hemoglobin levels and enabled nearly twice as many patients with transfusion-dependent, lower-risk myelodysplastic syndromes (MDS) to avoid red blood cell transfusions during the first 24 weeks of the study compared with standard-of-care epoetin alfa. Read More ›
On June 15, 2023, the FDA accelerated the approval of glofitamab-gxbm (Columvi; Genentech), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after ≥2 lines of systemic therapy. Read More ›
On May 19, 2023, the FDA accelerated the approval of epcoritamab-bysp (Epkinly; Genmab US), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma after ≥2 lines of systemic therapy. The FDA granted this application priority review. Read More ›
On April 17, 2023, the FDA approved omidubicel-onlv (Omisirge; Gamida Cell), a substantially modified allogeneic cord blood–based cell therapy, to quicken the recovery of neutrophils in the body and reduce the risk for infection in adults and pediatric patients aged ≥12 years with hematologic malignancies who have a planned umbilical cord blood transplant after a myeloablative conditioning regimen, such as radiation or chemotherapy. Read More ›
Ibrutinib (Imbruvica) may allow patients with newly diagnosed mantle-cell lymphoma (MCL) to forego autologous stem-cell transplantation (ASCT), according to results of the 3-arm randomized TRIANGLE clinical trial presented at the 64th American Society of Hematology Annual Meeting and Exposition. Read More ›
By William King
Results from the IFM2017-03 trial showed that a dexamethasone-sparing regimen of daratumumab (Darzalex) plus lenalidomide (Revlimid; DR) was superior to lenalidomide plus dexamethasone (Rd) in terms of response rates and rates of minimal residual disease (MRD) negativity in frail patients with newly diagnosed multiple myeloma. Read More ›
According to results from a clinical trial presented during the American Society of Clinical Oncology 2021 virtual annual meeting, aspacytarabine (BST-236), a prodrug of cytarabine, appears safe and effective as first-line therapy for patients with acute myeloid leukemia (AML) who are unfit for intensive chemotherapy. Read More ›
The novel BCL-2 inhibitor, lisaftoclax (APG-2575), elicited encouraging responses and acceptable tolerability in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and other hematologic malignancies, according to results of a phase 1 study presented at the American Society of Clinical Oncology 2021 virtual annual meeting. Read More ›