{"entity":{"id":"elranatamab","kind":"drug","name":"Elranatamab","aka":[],"tldr":"Elranatamab is Pfizer's BCMA bispecific, given under the skin every week then every two weeks, for myeloma after four prior lines.","summary":"Elranatamab is a humanised IgG2a BCMAxCD3 bispecific antibody that links T cells to BCMA-expressing plasma cells, given subcutaneously with step-up doses of 12 mg and 32 mg, then 76 mg weekly and every 2 weeks after 24 weeks in responders. In MagnetisMM-3, BCMA-naive patients had ORR 61% and CR 35% with median PFS of about 17 months, leading to accelerated approval in August 2023 after at least 4 prior lines. Cytokine release syndrome was common but mild; infections affected 70% (40% grade 3 or higher), so IVIG for hypogammaglobulinaemia and infection vigilance are central to its use. MagnetisMM-5 (with daratumumab, versus Dara-Pd) and MagnetisMM-7 (post-transplant maintenance) are the confirmatory phase 3 trials. Pfizer develops it. It is an off-the-shelf injection that recruits the patient's own T cells against myeloma without the manufacturing wait of CAR-T.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Elranatamab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Elranatamab"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":["bcma","cd3"],"drugs":[],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["crs","step-up-dosing"],"trials":["magnetismm-3","nct05623020","nct06152575","nct05020236","nct05317416","nct06988488","nct06106945"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Elrexfio","modality":"Bispecific T-cell engager (BCMA×CD3)","mechanism":"Humanised IgG2a BCMA×CD3 bispecific; step-up dosing 12 mg, 32 mg, then 76 mg weekly.","approvals":[{"region":"US","year":2023,"indication":"Relapsed/refractory myeloma after ≥4 lines (accelerated)"}],"mechanismSteps":[],"dosing":{"route":"Subcutaneous","schedule":"12 mg day 1, 32 mg day 4, 76 mg weekly from day 8; every 2 weeks after 24 weeks if responding","monitoring":"CRS/ICANS (48-hour hospitalisation after first two step-up doses), infections, IVIG for hypogammaglobulinaemia"},"toxicity":[{"event":"Cytokine release syndrome","anyGradePct":58,"grade3PlusPct":0,"note":"MagnetisMM-3 cohort A"},{"event":"Infections","anyGradePct":70,"grade3PlusPct":40},{"event":"Neutropenia","grade3PlusPct":49}],"access":[],"regulatoryEvents":[{"date":"2023-08-14","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 3.1 years later, when the FDA's table was read.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-elranatamab-bcmm-multiple-myeloma","indication":"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."}]},"route":"/drugs/elranatamab/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-relapsed-refractory","kind":"cancer","name":"Relapsed or refractory multiple myeloma","route":"/cancers/myeloma-relapsed-refractory/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"bcma","kind":"target","name":"BCMA","route":"/targets/bcma/"},{"id":"cd3","kind":"target","name":"CD3","route":"/targets/cd3/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"term":[{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"},{"id":"step-up-dosing","kind":"term","name":"Step-up dosing (T-cell engagers)","route":"/terms/step-up-dosing/"}],"trial":[{"id":"nct06988488","kind":"trial","name":"A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatama","route":"/trials/nct06988488/"},{"id":"nct05623020","kind":"trial","name":"A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide","route":"/trials/nct05623020/"},{"id":"nct05020236","kind":"trial","name":"A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments","route":"/trials/nct05020236/"},{"id":"nct06106945","kind":"trial","name":"AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma","route":"/trials/nct06106945/"},{"id":"magnetismm-3","kind":"trial","name":"MagnetisMM-3","route":"/trials/magnetismm-3/"},{"id":"nct06152575","kind":"trial","name":"MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other","route":"/trials/nct06152575/"},{"id":"nct05317416","kind":"trial","name":"Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant","route":"/trials/nct05317416/"}],"pairing":[{"id":"bispecific-infection-prophylaxis","kind":"pairing","name":"Caution: T-cell redirectors and infections","route":"/pairings/bispecific-infection-prophylaxis/"}],"paper":[{"id":"paper-magnetismm-3-elranatamab-natmed-2023","kind":"paper","name":"MagnetisMM-3: elranatamab, a second BCMA bispecific, with a switch to fortnightly dosing after response","route":"/key-papers/paper-magnetismm-3-elranatamab-natmed-2023/"},{"id":"paper-majestec-1-teclistamab-nejm-2022","kind":"paper","name":"MajesTEC-1: teclistamab, an off-the-shelf BCMA bispecific antibody, in heavily pretreated myeloma","route":"/key-papers/paper-majestec-1-teclistamab-nejm-2022/"}],"biomarker":[{"id":"bcma-expression","kind":"biomarker","name":"BCMA expression","route":"/biomarkers/bcma-expression/"}]}}