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Elrexfio (elranatamab)
Australian Prescription Medicine Decision Summary
Sponsor
ARTGs
Device/Product name
Elrexfio
Active Ingredient
elranatamab
Date of decision
Published
Submission type
Type A (New chemical entity)
ATC codes
not yet assigned
Decision
Provisionally registered
What was the decision based on
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.
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.
What steps were involved in the decision process
This submission was evaluated under the provisional registration process.
| Description | Date |
|---|---|
| Determination (Provisional) | 13 April 2023 |
| Submission dossier accepted and first round evaluation commenced | 31 May 2023 |
| Evaluation completed | 22 December 2023 |
| Delegate’s1 Overall benefit-risk assessment and request for Advisory Committee advice [add if applicable] | 4 March 2024 |
| Sponsor’s pre-Advisory Committee response | 19 March 2024 |
| Advisory Committee meeting | 1 May 2024 |
| Registration decision (Outcome) | 26 June 2024 |
| Administrative activities and registration in the ARTG completed | 28 June 2024 |
| Number of working days from submission dossier acceptance to registration decision2 | 275 |
- The ‘Delegate’ is the Delegate of the Secretary of the Department of Health and Aged Care who made the final decision to either include the new medicine/indication on the ARTG or reject the submission, under section 25 of the Therapeutic Goods Act.
Statutory timeframe for standard submissions is 255 working days
Date of entry onto ARTG
Black triangle scheme
Elrexfio is to be included in the Black Triangle Scheme. The PI and CMI for Elrexfio must include the black triangle symbol and mandatory accompanying text for five years, or the product’s entire period of provisional registration, whichever is longer. The black triangle is a visual reminder to encourage health practitioners and patients to report a problem or side effect with this medicine.
Dose forms
Solution for injection.
Strength
40 mg/mL solution
Other ingredients
Histidine
Histidine hydrochloride monohydrate
Disodium edetate
Polysorbate 80
Sucrose
Containers
Single-dose vial (Type 1 glass) with a stopper (butyl rubber) and an aluminium seal with a flip-off cap
Pack sizes
1 vial
Routes of administration
Subcutaneous injection
Dosage
The recommended doses of Elrexfio are step-up doses of 12 mg on Day 1 and 32 mg on Day 4 followed by a full treatment dose of 76 mg weekly, from Week 2 to Week 24.
For patients who have received at least 24 weeks of treatment with ELREXFIO and have achieved a response, the dosing interval should transition to an every two-week schedule.
Treatment with Elrexfio should be continued until disease progression or unacceptable toxicity.
Pregnancy category
C:
Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
There are no data on the use of ELREXFIO in pregnant women. No embryofetal development studies have been conducted with elranatamab in animals.
ELREXFIO is not recommended for use during pregnancy. The pregnancy status of women of child-bearing potential should be verified prior to initiating treatment with ELREXFIO.
Human immunoglobulin (IgG) is known to cross the placenta after the first trimester of pregnancy. Based on the mechanism of action, elranatamab may cause fetal harm, including B-cell lymphocytopenia, when administered to a pregnant woman. Fetal B-cell depletion poses a risk of opportunistic infections in the neonate. Elranatamab-induced cytokine release may also pose a risk for embryofetal loss.
ELREXFIO is associated with hypogammaglobulinaemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with ELREXFIO should be considered. Postponing vaccination with live or live-attenuated vaccines is recommended for neonates and infants who have been exposed to elranatamab in utero until B-cell levels have recovered.
Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
There are no data on the use of ELREXFIO in pregnant women. No embryofetal development studies have been conducted with elranatamab in animals.
ELREXFIO is not recommended for use during pregnancy. The pregnancy status of women of child-bearing potential should be verified prior to initiating treatment with ELREXFIO.
Human immunoglobulin (IgG) is known to cross the placenta after the first trimester of pregnancy. Based on the mechanism of action, elranatamab may cause fetal harm, including B-cell lymphocytopenia, when administered to a pregnant woman. Fetal B-cell depletion poses a risk of opportunistic infections in the neonate. Elranatamab-induced cytokine release may also pose a risk for embryofetal loss.
ELREXFIO is associated with hypogammaglobulinaemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with ELREXFIO should be considered. Postponing vaccination with live or live-attenuated vaccines is recommended for neonates and infants who have been exposed to elranatamab in utero until B-cell levels have recovered.
What was approved
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.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
Clinical commitments:
• The sponsor must conduct studies as described in the clinical study plan in version of the Australia-Specific Annex.
• Conduct and submit data from Study C1071005 (MAGNETISMM-5) to the TGA for
evaluation.
• Submit the final clinical study report for Study C1071003 to the TGA for
evaluation.
Elrexfio (elranatamab) is to be included in the Black Triangle Scheme. The PI and CMI for Elrexfio must include the black triangle symbol and mandatory accompanying text for five years, or the product’s entire period of provisional registration, whichever is longer.
RMP commitments:
The Elrexfio Risk Management Plan (RMP) as agreed with the TGA will be implemented in Australia. An obligatory component of RMPs is routine pharmacovigilance, which includes the submission of periodic safety update reports.
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.