FDA clearance reached AbbVie’s CD123-targeting antibody-drug conjugate Decnupaz (pivekimab sunirine) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), marking a regulatory win for a therapy acquired via Immunogen in 2023. The clearance is supported by Phase 1/2 Cadenza study data, positioning the ADC for use in an ultra-rare, aggressive hematologic malignancy. At the same time, Replimune received new momentum after reaching alignment with the FDA to resubmit RP-1 (vusolimogene oderparepvec) for advanced melanoma in combination with nivolumab. The company said the FDA pledged to prioritize review following two prior complete response letters, underscoring how agency leadership changes are coinciding with new submission strategies. Together, the decisions show how FDA review posture and evidence packaging continue to drive near-term oncology access—both for first approvals in rare cancers and for second-chance submissions in late-stage immuno-oncology combinations.