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Relapsed or refractory multiple myeloma Clinical criteria: Treatment Phase: Continuing treatment Patient must have previously received treatment with this drug for this condition, AND Patient must have had progressive disease after receiving at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, and (iii) an anti-CD38 monoclonal antibody; OR Patient must have been refractory to, at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, (iii) an anti-CD38 monoclonal antibody, AND Patient must not have previously received treatment with another B-cell maturation antigen (BCMA) directed therapy for this condition, AND Patient must have a WHO performance status of 2 or less prior to initiating treatment with this drug for this condition, AND Patient must not have developed disease progression while receiving treatment with this drug for this condition, AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. Progressive disease is defined as at least 1 of the following: (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Prescribers may request the number of vials in line with the dosing requirement for each stage of treatment with the intention of providing the number of vials for each 4-weeks of treatment (24-weeks of treatment including repeats). Up to 4 vials with 5 repeats may be requested for a patient undergoing treatment in weeks 2-26. Up to 2 vials with 5 repeats may be requested for a patient undergoing treatment from week 27 onwards. Requests beyond what is listed in the TGA approved product information will not be approved. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
“Elranatamab is a bispecific antibody that binds B-cell maturation antigen (BCMA) expressed on plasma cells, plasmablasts, and multiple myeloma cells and CD3 expressed on T cells. Simultaneous binding of BCMA and CD3 by elranatamab leads to T-cell activation and proliferation and the release of pro-inflammatory cytokines, resulting in the lysis of BCMA- expressing tumour and normal cells.”
“The predicted geometric mean half-life of elranatamab is 22, 64% (CV) days at week 24 following doses of 76 mg weekly.”
Working under the parallel aged-care framework? Aged-care equivalent →
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“ELREXFIO causes release of cytokines that may suppress activity of cytochrome P450 (CYP) enzymes, resulting in increased exposure of CYP substrates. Increased exposure of CYP substrates is more likely to occur after the first dose of ELREXFIO and up to 14 days after a subsequent step-up dose, as well as during and after CRS.”