{"entity":{"id":"pivekimab-sunirine","kind":"drug","name":"Pivekimab sunirine","aka":[],"tldr":"Pivekimab sunirine is an antibody-drug conjugate against CD123, approved in 2026 for blastic plasmacytoid dendritic cell neoplasm as the second targeted drug for this rare cancer.","summary":"Pivekimab sunirine is an antibody-drug conjugate: an anti-CD123 antibody joined by a cleavable linker to an indolinobenzodiazepine pseudodimer (IGN) payload that alkylates DNA without cross-linking. CD123 is highly expressed on blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive haematological cancer. The CADENZA pivotal study in untreated BPDCN showed high complete response rates with fewer capillary-leak events than tagraxofusp, the first CD123-directed drug, and the FDA approved it in May 2026, making it the second targeted therapy for this disease. It is also being studied in CD123-positive AML in combination with azacitidine and venetoclax. Whether it improves long-term survival and how it should be sequenced with transplant remain open. For a newcomer, it delivers a DNA-damaging payload directly to cells that carry the CD123 marker.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Pivekimab_sunirine","links":[{"label":"FDA novel approvals 2026","url":"https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026"}],"tags":["gap-fill"],"related":[],"cancers":["bpdcn","aml"],"sections":[],"technologies":["adc"],"targets":["cd123"],"drugs":[],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":["nct03386513","nct07581002","nct04086264"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Decnupaz","code":"IMGN632","modality":"ADC (anti-CD123 antibody, IGN payload)","mechanism":"Anti-CD123 antibody conjugated via a cleavable linker to an indolinobenzodiazepine pseudodimer (IGN) that alkylates DNA without cross-linking.","approvals":[{"region":"US","year":2026,"indication":"Blastic plasmacytoid dendritic cell neoplasm"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2026-05-27","type":"approval","region":"US","note":"FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare"}]},"route":"/drugs/pivekimab-sunirine/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"bpdcn","kind":"cancer","name":"Blastic plasmacytoid dendritic cell neoplasm (BPDCN)","route":"/cancers/bpdcn/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"cd123","kind":"target","name":"CD123","route":"/targets/cd123/"}],"company":[{"id":"abbvie","kind":"company","name":"AbbVie (incl. ImmunoGen, Capstan)","route":"/companies/abbvie/"}],"trial":[{"id":"nct07581002","kind":"trial","name":"A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML)","route":"/trials/nct07581002/"},{"id":"nct04086264","kind":"trial","name":"IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia","route":"/trials/nct04086264/"},{"id":"nct03386513","kind":"trial","name":"Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN","route":"/trials/nct03386513/"}]}}