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]
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]
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]
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]
^ abcd"Elrexfio EPAR". European Medicines Agency (EMA). 12 October 2023. Retrieved 27 December 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ abcd"Elrexfio PI". Union Register of medicinal products. 8 December 2023. Retrieved 27 December 2023.
^World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87". WHO Drug Information. 36 (1). hdl:10665/352794.
Clinical trial number NCT04649359 for "MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb" at ClinicalTrials.gov
