SFDA Approves Elrexfio for Multiple Myeloma Treatment
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: [email protected]
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SFDA Approves Elrexfio for Multiple Myeloma Treatment
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: [email protected] Related Topics : SFDA Reports Record 82% Surge in Licensed Factories, Warehouses in 2024 Is wheat harmful to the intestine? SFDA clarifies the truth New Corona vaccines to arrive at the Kingdom: SFDA SFDA: National Biotechnology Strategy Highlights Saudi Leadership in Medical Innovation Short link : Post Views: 7 Related Stories
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