Top Qs
Timeline
Chat
Perspective
Elranatamab
Medication From Wikipedia, the free encyclopedia
Remove ads
Elranatamab, sold under the brand name Elrexfio, is a medication used for the treatment of multiple myeloma.[8][12] Elranatamab is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.[8][12][13][14] Elranatamab is given by subcutaneous injection.[8][12]
The most common side effects include cytokine release syndrome, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia (fever).[12]
Elranatamab was approved for medical use in the United States in August 2023,[8][12][15][16] in the European Union in December 2023,[11] and in Canada in December 2023.[5]
Remove ads
Medical uses
Elranatamab is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.[8][12]
Adverse effects
The most common adverse reactions include cytokine release syndrome, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia.[12]
The US Food and Drug Administration (FDA) prescribing information for elranatamab has a boxed warning for life-threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity.[12]
Remove ads
History
The safety and effectiveness of elranatamab was evaluated in MagnetisMM-3 (NCT04649359), an open-label, single-arm, multi-center study that included participants with relapsed/refractory multiple myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody.[12] Overall, the study consisted of 97 participants naïve to prior BCMA-directed therapy and who had previously received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.[12]
The FDA granted the application for elranatamab priority review, breakthrough therapy, and orphan drug designations;[12] and granted approval of Elrexfio to Pfizer Inc.[12]
Society and culture
Legal status
In October 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Elrexfio, intended for the treatment of multiple myeloma.[10] The applicant for this medicinal product is Pfizer Europe MA EEIG.[10]
In 2023, elranatamab was approved for medical use in the United States,[8][12] in the European Union,[10][11] and in Canada.[5]
Brand names
Elranatamab is the international nonproprietary name.[17]
Elranatamab is sold under the brand name Elrexfio.[4][8][11]
Remove ads
References
External links
Wikiwand - on
Seamless Wikipedia browsing. On steroids.
Remove ads