Hematologic Malignancies
On September 11, 2023, the FDA approved motixafortide (Aphexda; BioLineRx) subcutaneous injection, a hematopoietic stem cell mobilizer, for use in combination with the granulocyte colony-stimulating factor filgrastim (Neupogen; Amgen), to mobilize HSCs to the peripheral blood for collection and subsequent autologous stem cell transplantation in patients with multiple myeloma. Motixafortide is the first novel stem cell mobilizer in a decade to receive FDA approval for multiple myeloma. Read More ›
On September 26, 2023, the FDA approved a new indication for bosutinib (Bosulif; Pfizer), a tyrosine kinase inhibitor, for the treatment of chronic-phase, Philadelphia chromosome–positive chronic myelogenous leukemia in pediatric patients aged ≥1 years who are newly diagnosed or who are intolerant of or whose disease is resistant to previous therapy. A new capsule dosage form was also FDA approved, in 50-mg and 100-mg strengths; bosutinib was previously available only in 100-mg, 400-mg, and 500-mg tablet forms. The FDA granted this approval priority review and an orphan drug designation. Read More ›
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 ›