{"entity":{"id":"tafasitamab","kind":"drug","name":"Tafasitamab","aka":[],"tldr":"A CD19 antibody given with lenalidomide for lymphoma patients who cannot have a transplant; in 2026 it showed the first frontline gain over R-CHOP in high-risk disease.","summary":"L-MIND (single arm, with lenalidomide): ORR 60%, CR 43%, median DOR ~44 months; accelerated approval July 2020 for transplant-ineligible R/R DLBCL. frontMIND phase 3 (Lancet 2026): tafasitamab + lenalidomide + R-CHOP vs placebo + R-CHOP in IPI 3-5 DLBCL; 2-year PFS 71.1% vs 62.9%, HR 0.75; OS immature (HR 0.85). Also approved 2025 with lenalidomide-rituximab in follicular lymphoma (inMIND).","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Tafasitamab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Tafasitamab"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["cd19"],"drugs":["lenalidomide"],"companies":["incyte","morphosys"],"institutions":[],"pathways":[],"terms":["adcc"],"trials":["l-mind","frontmind","nct05429268","nct04680052","nct05222555","nct03930953","nct06465433"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Monjuvi","modality":"Monoclonal antibody (anti-CD19, Fc-enhanced)","mechanism":"Fc-engineered (XmAb) anti-CD19 antibody with enhanced ADCC/ADCP; lenalidomide augments NK activity.","approvals":[{"region":"US","year":2020,"indication":"R/R DLBCL with lenalidomide, transplant-ineligible (accelerated)"},{"region":"US","year":2025,"indication":"R/R follicular lymphoma with lenalidomide and rituximab"},{"region":"EU","year":2021,"indication":"EU brand Minjuvi","note":"Conditional marketing authorisation"}],"mechanismSteps":[],"dosing":{"route":"IV","schedule":"12 mg/kg days 1, 8, 15, 22 of cycles 1-3, then days 1 and 15 from cycle 4; lenalidomide 25 mg days 1-21 for up to 12 cycles, tafasitamab until progression","monitoring":"Cytopenias, infections, infusion reactions"},"toxicity":[{"event":"Neutropenia","grade3PlusPct":48,"note":"L-MIND, with lenalidomide"},{"event":"Thrombocytopenia","grade3PlusPct":17},{"event":"Febrile neutropenia","grade3PlusPct":12}],"access":[],"regulatoryEvents":[{"date":"2020-07-31","type":"accelerated-approval","region":"US","note":"L-MIND accelerated approval The confirmatory requirement was still open 6.1 years later, when the FDA's table was read.","indication":"In combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT)."},{"date":"2026-03","type":"filing","region":"US","note":"sBLA for frontline high-risk DLBCL (frontMIND) planned H1 2026","source":"https://www.onclive.com/view/frontmind-results-tafasitamab-based-combo-yields-significant-pfs-benefit-over-r-chop-in-frontline-high-risk-dlbcl"}]},"route":"/drugs/tafasitamab/","neighbours":{"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"}],"drug":[{"id":"lenalidomide","kind":"drug","name":"Lenalidomide","route":"/drugs/lenalidomide/"}],"company":[{"id":"incyte","kind":"company","name":"Incyte","route":"/companies/incyte/"},{"id":"morphosys","kind":"company","name":"MorphoSys (Novartis)","route":"/companies/morphosys/"}],"term":[{"id":"adcc","kind":"term","name":"ADCC (antibody-dependent cellular cytotoxicity)","route":"/terms/adcc/"},{"id":"lymphoma-tx-uk-access","kind":"term","name":"What the NHS in England funds for lymphoma, appraisal by appraisal","route":"/terms/lymphoma-tx-uk-access/"}],"trial":[{"id":"nct04680052","kind":"trial","name":"A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Pa","route":"/trials/nct04680052/"},{"id":"nct03930953","kind":"trial","name":"A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory No","route":"/trials/nct03930953/"},{"id":"nct06465433","kind":"trial","name":"Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab","route":"/trials/nct06465433/"},{"id":"frontmind","kind":"trial","name":"frontMIND","route":"/trials/frontmind/"},{"id":"l-mind","kind":"trial","name":"L-MIND","route":"/trials/l-mind/"},{"id":"nct05222555","kind":"trial","name":"Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients","route":"/trials/nct05222555/"},{"id":"nct05429268","kind":"trial","name":"Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (","route":"/trials/nct05429268/"},{"id":"nct04661007","kind":"trial","name":"To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL","route":"/trials/nct04661007/"}],"paper":[{"id":"paper-inmind-tafasitamab-lenalidomide-rituximab-follicular-lancet-2026","kind":"paper","name":"Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial","route":"/key-papers/paper-inmind-tafasitamab-lenalidomide-rituximab-follicular-lancet-2026/"}],"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"biomarker":[{"id":"cd19-expression","kind":"biomarker","name":"CD19 expression (CD19-positive)","route":"/biomarkers/cd19-expression/"}]}}