SFDA Approves Elrexfio For Treating Adults With Relapsed Multiple Myeloma

The Saudi Food and Drug Authority (SFDA) has approved Elrexfio (Elranatamab) for adults with relapsed or refractory multiple myeloma. This approval is for patients who have undergone at least four prior treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Elrexfio has received orphan drug designation under the SFDA's program.

Elrexfio contains Elranatamab, a bispecific antibody targeting BCMA on myeloma cells and CD3 on T-cells. This dual targeting activates T-cells to release cytokines and destroy cancerous cells. The SFDA's approval followed a thorough evaluation of its efficacy, safety, and quality according to regulatory standards.

Clinical trials showed a 58% overall response rate in patients with relapsed or refractory multiple myeloma after at least four prior therapies. Among responders, 82% maintained their response for nine months or more. Elrexfio is administered subcutaneously, starting with three step-up doses in the first week, then weekly until Week 24, and biweekly thereafter.

The SFDA's Orphan Drug Designation Program aims to improve access to treatments for rare diseases. An orphan drug treats conditions affecting fewer than five individuals per 10,000 people in Saudi Arabia. This program accelerates access to promising therapies addressing unmet medical needs.

Common side effects reported in studies include cytokine release syndrome (CRS), injection site reactions, respiratory infections, musculoskeletal pain, fatigue, and diarrhea. These findings underscore the importance of monitoring patients closely during treatment.

The approval of Elrexfio highlights SFDA's dedication to providing treatments for rare and challenging diseases through its Orphan Drug Designation Program. This initiative is crucial for facilitating access to innovative therapies that meet significant medical needs.

With inputs from SPA