FDA approves Elrexfio for relapsed or refractory multiple myeloma
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The FDA granted accelerated approval to elranatamab-bcmm for treatment of certain patients with multiple myeloma.
The approval applies to use of the agent by adults with relapsed or refractory disease who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Elranatamab-bcmm (Elrexfio, Pfizer) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.
The FDA based the approval in part on results of the phase 2, single-arm study.
The primary efficacy population included 97 patients with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy and were refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody.
All patients were naive to prior BCMA-directed therapy and had measurable disease by International Myeloma Working Group criteria at enrollment.
Objective response rate and duration of response assessed by blinded independent central review served as the main efficacy outcomes.
Researchers reported an ORR of 57.7% (95% CI, 47.3-67.7). After median follow-up of 11.1 months, median duration of response among patients who responded to treatment had not been reached (95% CI, 12 months to not reached); however, the majority remained in response for at least 9 months (82.3%; 95% CI, 67.1-90.6).
Elranatamab-bcmm is available only through a restricted program under a Risk Evaluation and Mitigation Strategy.
The prescribing information includes a boxed warning for life-threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS).
Analyses of patients who received elranatamab-bcmm at the recommended dose showed 58% developed CRS (grade 3, 0.5%), 59% developed neurologic toxicity (grade 3/grade 4, 7%) and 3.3% developed ICANS.
The most common adverse events reported among at least 20% of patients treated with the therapy included CRS, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea and pyrexia. The most common grade 3 to grade 4 laboratory abnormalities included decreases in lymphocytes, neutrophils, hemoglobin, white blood cells and platelets.
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