Pivekimab sunirine (PVEK)

Note: APPROVED EARLY — FDA acted on 2026-05-27, about two months AHEAD of the 2026-07-30 target action date we had on file. That early action is why the automated window scan found "no FDA approval found in window" — the search window was anchored on the July date. Brand name: DECNUPAZ (pivekimab sunirine-pvzy). Approval date: 2026-05-27. Indication: adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare aggressive hematologic malignancy. It is a CD123-directed antibody-drug conjugate (antibody + alkylating agent conjugate) and is AbbVie's first ADC approved in a blood cancer; per AbbVie it is the first and only ADC for BPDCN that is initiated in an outpatient setting. Asset origin: ImmunoGen (IMGN632), acquired by AbbVie in Feb 2024. Basis: Phase 1/2 CADENZA trial. Prior designations: Breakthrough Therapy (Oct 2020, r/r BPDCN) and orphan drug; BLA submitted September 2025. Label carries a Boxed Warning for hepatotoxicity including hepatic veno-occlusive disease. Primary source verified by opening AbbVie's official newsroom press release (news.abbvie.com), dated 2026-05-27; the FDA oncology approval notice corroborates the same date and the -pvzy suffix but its page 404'd when fetched directly, so it is not cited as the primary. NO evidence of any second/separate pivekimab BLA with a 2026-07-30 action date — searches for one returned nothing; the AML combination program (pivekimab + venetoclax/azacitidine, REVIVAL) is still in Phase 2/3 and has no pending application. Recommended action: update data/pdufa-outcomes-manual.json to outcome=approved with outcomeDate 2026-05-27 and note that FDA acted ahead of the recorded goal date, and consider correcting the stored PDUFA target (2026-07-30 looks like an estimated goal date rather than a company-confirmed one — worth re-verifying against the BLA acceptance release before trusting it elsewhere). FDA acted 2026-05-27 (target was 2026-07-30). Source: https://news.abbvie.com/2026-05-27-U-S-FDA-Approves-DECNUPAZTM-pivekimab-sunirine-pvzy-for-Treatment-of-Adult-Patients-with-Blastic-Plasmacytoid-Dendritic-Cell-Neoplasm,-an-Ultra-Rare-and-Aggressive-Blood-Cancer-With-Limited-Treatment-Options