The Saudi Food and Drug Authority (SFDA) has approved the registration of Elrexfio (Elranatamab) for adult patients with relapsed or refractory multiple myeloma who have undergone at least four prior lines of therapy. These previous treatments must have included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Elrexfio has been granted orphan drug designation under the SFDA Orphan Drug Designation Program.
How Elrexfio Works?
Elrexfio contains Elranatamab, a bispecific antibody designed to target:
- BCMA – a protein found on multiple myeloma cells
- CD3 – a receptor on T-cells
By binding to both targets, Elrexfio activates T-cells to release immune signals (cytokines) and directly destroy malignant myeloma cells.
SFDA’s decision followed a thorough evaluation of Elrexfio’s efficacy, safety, and quality according to regulatory standards. Clinical trial data showed:
- 58% overall response rate in patients with relapsed or refractory multiple myeloma after at least four prior lines of therapy
- 82% of responders maintained their response for at least nine months
Dosage, Administration
Elrexfio is administered as a subcutaneous injection:
- Three step-up doses in the first week
- Once-weekly dosing up to Week 24
- Once every two weeks thereafter
Safety Profile
The most common side effects observed in clinical studies included:
- Cytokine release syndrome (CRS)
- Injection site reactions
- Respiratory tract infections
- Musculoskeletal pain
- Fatigue
- Diarrhea
Commitment to Rare Disease Treatment
This approval reflects SFDA’s commitment to improving access to therapies for rare and hard-to-treat conditions through the Orphan Drug Designation Program.
In Saudi Arabia, a rare disease is defined as affecting fewer than 5 people per 10,000 in the population.
For more details about the Orphan Drugs Guideline, visit:
SFDA Orphan Drugs Guideline
Or contact SFDA at: Designation.Drug@sfda.gov.sa
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