{"entity":{"id":"teclistamab","kind":"drug","name":"Teclistamab","aka":[],"tldr":"Teclistamab was the first off-the-shelf bispecific for multiple myeloma, and is now approved after just one prior line of therapy.","summary":"Teclistamab is a humanised IgG4 DuoBody bispecific that binds BCMA on myeloma cells with one arm and CD3 on T cells with the other, forming an artificial immune synapse that kills the tumour cell independent of MHC. It was the first off-the-shelf bispecific for myeloma, given subcutaneously after step-up doses of 0.06 and 0.3 mg/kg, then 1.5 mg/kg weekly, with less frequent dosing in sustained responders. Accelerated approval in 2022 rested on MajesTEC-1 in heavily pretreated myeloma (objective response rate 63 percent), and in the first quarter of 2026 the label expanded to relapsed or refractory myeloma after at least one prior therapy, with daratumumab, based on MajesTEC-3. Cytokine release syndrome occurred in 72 percent of MajesTEC-1 patients but was severe in under 1 percent, and serious infections affected 30 to 54 percent across trials, so infection prophylaxis is essential.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Teclistamab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Teclistamab"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":["bcma","cd3"],"drugs":[],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05572515","nct06208150","nct05552222","nct04586426","nct06577025"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Tecvayli","modality":"Bispecific T-cell engager (BCMA×CD3)","mechanism":"Humanised IgG4 BCMA×CD3 DuoBody.","approvals":[{"region":"US","year":2022,"indication":"Relapsed/refractory myeloma after ≥4 lines"},{"region":"US","year":2026,"indication":"Relapsed/refractory myeloma after ≥1 prior therapy"},{"region":"EU","year":2022,"indication":"R/R myeloma ≥3 lines (conditional, Aug 2022)","note":"Conditional marketing authorisation"}],"mechanismSteps":["One arm binds BCMA on the tumour cell","The other arm binds CD3 on any passing T cell","An artificial immune synapse forms, independent of MHC","The T cell releases perforin and granzymes into the tumour cell","Tumour cell dies; cytokines are released (source of CRS)"],"dosing":{"route":"Subcutaneous injection","schedule":"Step-up 0.06 then 0.3 mg/kg, then 1.5 mg/kg weekly; may move to 3 mg/kg every 2 weeks after ≥6 months of response, then every 4 weeks","modifications":"Hold for grade ≥2 CRS/ICANS; IVIG for hypogammaglobulinaemia; antimicrobial prophylaxis","monitoring":"48-hour hospitalisation after each step-up dose; infections, IgG levels, blood counts","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e"},"toxicity":[{"event":"Pyrexia","anyGradePct":76,"grade3PlusPct":3,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e","note":"MajesTEC-1"},{"event":"Cytokine release syndrome","anyGradePct":72,"grade3PlusPct":0.6,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e","note":"MajesTEC-1"},{"event":"Neutrophils decreased","anyGradePct":88,"grade3PlusPct":70,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e","note":"MajesTEC-1"},{"event":"Musculoskeletal pain","anyGradePct":44,"grade3PlusPct":4.2,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e","note":"MajesTEC-1"},{"event":"Injection site reaction","anyGradePct":37,"grade3PlusPct":0.6,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e","note":"MajesTEC-1"},{"event":"Fatigue","anyGradePct":33,"grade3PlusPct":2.4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e","note":"MajesTEC-1"},{"event":"Pneumonia","anyGradePct":24,"grade3PlusPct":15,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e","note":"MajesTEC-1"},{"event":"Neurologic toxicity","anyGradePct":60,"grade3PlusPct":6,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e","note":"ICANS 6%"},{"event":"Serious infections","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e","note":"30-54% across trials; fatal 4-5%"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.janssencarepath.com","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for relapsed/refractory myeloma after ≥3 therapies (TA1006)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2021-06","type":"designation","region":"US","note":"Breakthrough Therapy designation","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2022-08-24","type":"approval","region":"EU","note":"Conditional approval: first BCMA bispecific worldwide","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2022-10-25","type":"accelerated-approval","region":"US","note":"Accelerated approval, relapsed/refractory myeloma after ≥4 lines (MajesTEC-1)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Adult patients 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"},{"date":"2024-02-20","type":"label-change","region":"US","note":"Biweekly dosing added for responders","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-Q1","type":"approval","region":"US","note":"Relapsed/refractory myeloma after ≥1 prior line, with daratumumab (MajesTEC-3)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-03-05","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2022 converted to traditional approval 3.4 years after it was granted.","indication":"Adult patients 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/teclistamab/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-transplant-ineligible","kind":"cancer","name":"Newly diagnosed multiple myeloma, transplant-ineligible","route":"/cancers/myeloma-transplant-ineligible/"},{"id":"plasma-cell-leukaemia","kind":"cancer","name":"Plasma cell leukaemia","route":"/cancers/plasma-cell-leukaemia/"},{"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":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"trial":[{"id":"nct06208150","kind":"trial","name":"A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortez","route":"/trials/nct06208150/"},{"id":"nct05572515","kind":"trial","name":"A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With","route":"/trials/nct05572515/"},{"id":"nct06577025","kind":"trial","name":"A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Ind","route":"/trials/nct06577025/"},{"id":"nct05552222","kind":"trial","name":"A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal","route":"/trials/nct05552222/"},{"id":"nct04586426","kind":"trial","name":"A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma","route":"/trials/nct04586426/"},{"id":"majestec-1","kind":"trial","name":"MajesTEC-1","route":"/trials/majestec-1/"},{"id":"majestec-3","kind":"trial","name":"MajesTEC-3","route":"/trials/majestec-3/"}],"pairing":[{"id":"bcma-then-gprc5d","kind":"pairing","name":"BCMA-directed therapy → GPRC5D-directed therapy","route":"/pairings/bcma-then-gprc5d/"},{"id":"bispecific-infection-prophylaxis","kind":"pairing","name":"Caution: T-cell redirectors and infections","route":"/pairings/bispecific-infection-prophylaxis/"}],"roadmap":[{"id":"cell-therapy-roadmap","kind":"roadmap","name":"Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR","route":"/roadmaps/cell-therapy-roadmap/"}],"person":[{"id":"philippe-moreau","kind":"person","name":"Philippe Moreau","route":"/people/philippe-moreau/"},{"id":"saad-usmani","kind":"person","name":"Saad Z. Usmani","route":"/people/saad-usmani/"},{"id":"sundar-jagannath","kind":"person","name":"Sundar Jagannath","route":"/people/sundar-jagannath/"}],"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/"}],"term":[{"id":"hypogammaglobulinaemia","kind":"term","name":"Hypogammaglobulinaemia and infection risk after B-cell therapies","route":"/terms/hypogammaglobulinaemia/"},{"id":"step-up-dosing","kind":"term","name":"Step-up dosing (T-cell engagers)","route":"/terms/step-up-dosing/"}],"institution":[{"id":"ccc-wuerzburg","kind":"institution","name":"Comprehensive Cancer Center Mainfranken, University Hospital Würzburg","route":"/institutions/ccc-wuerzburg/"},{"id":"sant-orsola-bologna","kind":"institution","name":"IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola","route":"/institutions/sant-orsola-bologna/"},{"id":"iuct-oncopole","kind":"institution","name":"IUCT Oncopole (Institut Universitaire du Cancer de Toulouse)","route":"/institutions/iuct-oncopole/"},{"id":"yoda-project","kind":"institution","name":"Yale University Open Data Access (YODA) Project","route":"/institutions/yoda-project/"}],"drug":[{"id":"isb-2001","kind":"drug","name":"ISB 2001","route":"/drugs/isb-2001/"}],"biomarker":[{"id":"bcma-expression","kind":"biomarker","name":"BCMA expression","route":"/biomarkers/bcma-expression/"}]}}