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Elrexfio (elranatamab)
Australian Prescription Medicine Decision Summary
Published
Product name
Elrexfio
Active ingredient
elranatamab
Submission type
Type A (New chemical entity)
Decision
Provisionally registered
Decision date
Registration date
What this medicine was approved for
Elrexfio elranatamab was provisionally approved in Australia for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody and have demonstrated disease progression on the last therapy.
How this medicine works
Antibodies are proteins made by B cells of the immune system that bind with high specificity to markers on cells or tissues. Antibodies can also be synthesised in the laboratory. Elranatamab is a bispecific antibody which has been engineered to bind to two targets: the B cell maturation antigen (BCMA) on the surface of bone marrow cancer cells and CD3 on the surface of T cells (cells of the immune system that are capable of killing cancer cells). Elranatamab brings these two cell types together. This activates the T cells, which then kill the cancer cells.
Why the TGA approved or did not approve this medicine
The decision to provisionally register Elrexfio was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor.
The clinical data submitted by the Sponsor supported a decision for provisional registration, principally, the pivotal study C1071003. This study is an ongoing Phase 2, open-label, multicentre, nonrandomised study to evaluate the efficacy and safety of elranatamab monotherapy in participants with multiple myeloma.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlinks below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlinks below.
Sponsor
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.