{"entity":{"id":"ofatumumab","kind":"drug","name":"Ofatumumab","aka":["Kesimpta (multiple sclerosis formulation)"],"tldr":"Ofatumumab (Arzerra) is a fully human anti-CD20 antibody for chronic lymphocytic leukaemia, used with chlorambucil in untreated patients or alone after other drugs have failed; the same molecule is sold as Kesimpta for multiple sclerosis.","summary":"Ofatumumab received accelerated FDA approval in October 2009 for CLL refractory to fludarabine and alemtuzumab, then full approvals with chlorambucil in previously untreated CLL where fludarabine is inappropriate (COMPLEMENT-1, 2014: longer progression-free survival than chlorambucil alone), as extended treatment in recurrent or progressive CLL after response (PROLONG, 2016) and with fludarabine and cyclophosphamide in relapsed CLL (COMPLEMENT-2, 2016). The EU granted conditional authorisation in 2010; the marketing authorisation was later withdrawn for commercial reasons and Arzerra is now supplied in many countries through a compassionate programme, while Kesimpta (subcutaneous ofatumumab) is marketed for multiple sclerosis. Hepatitis B reactivation and progressive multifocal leukoencephalopathy carry boxed warnings.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Ofatumumab","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=ofatumumab"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/ofatumumab"}],"tags":["nci-list"],"related":["rituximab","obinutuzumab"],"cancers":["cll"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["cd20"],"drugs":[],"companies":["novartis","genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Arzerra","modality":"Monoclonal antibody (anti-CD20, fully human IgG1)","mechanism":"Binds a distinct small- and large-loop epitope of CD20 close to the membrane, giving potent complement-dependent cytotoxicity as well as antibody-dependent cellular cytotoxicity against B cells.","approvals":[{"region":"US","year":2009,"indication":"CLL refractory to fludarabine and alemtuzumab (accelerated)"},{"region":"US","year":2014,"indication":"Previously untreated CLL with chlorambucil; later extended treatment and relapsed CLL with fludarabine and cyclophosphamide"},{"region":"EU","year":2010,"indication":"CLL refractory to fludarabine and alemtuzumab (conditional; authorisation since withdrawn)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2009-10-26","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab"},{"date":"2014-04-17","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2009 converted to traditional approval 4.5 years after it was granted.","indication":"Chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab"}]},"route":"/drugs/ofatumumab/","neighbours":{"drug":[{"id":"obinutuzumab","kind":"drug","name":"Obinutuzumab","route":"/drugs/obinutuzumab/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"}],"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"company":[{"id":"genmab","kind":"company","name":"Genmab","route":"/companies/genmab/"},{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"trial":[{"id":"resonate","kind":"trial","name":"RESONATE","route":"/trials/resonate/"}]}}