Multiple Myeloma

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.
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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.
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Response to treatment with a regimen of daratumumab (Darzalex) plus lenalidomide (Revlimid; DR) was greater and minimal residual disease (MRD) was achieved more frequently compared with a regimen of lenalidomide plus dexamethasone (Rd) in the first randomized phase 3 clinical trial dedicated to frail, transplant-ineligible patients with newly diagnosed multiple myeloma.
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Meta-analysis of whole-body MRI versus FDG PET/CT to assess treatment response in MM may suggest a complementary benefit when utilizing both modalities.
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Updated phase 2 results of the MonumenTAL-1 study showed promising efficacy and a tolerable safety profile with talquetamab, a novel T-cell–redirecting bispecific antibody, in patients with RRMM.
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Real-world analysis of patients with MM determines treatment patterns and survival outcomes in patients with t(11;14) compared to patients with high- and standard-risk cytogenetics.
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REGN5458, a BCMAxCD38 bispecific antibody, demonstrated early durable responses with a tolerable safety profile and low rates of CRS in patients with relapsed/refractory multiple myeloma.
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Phase 2 results from MajesTEC-1 showed substantial clinical activity with teclistamab and are consistent with phase 1 findings.
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Long-term outcomes from MAIA support the use of daratumumab plus lenalidomide and dexamethasone for ≥18 months in newly diagnosed, transplant ineligible MM patients.
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