Shots:
- The US FDA has received BLA of Pivekimab sunirine (PVEK) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- The BLA is backed by the P-I/II (CADENZA) trial, which evaluated PVEK monotx. to establish the MTD, RP2D, & dosing schedule, while assessing safety, tolerability, PK, immunogenicity, & antileukemia activity in pts with CD123+ hematologic malignancies, incl. BPDCN & acute myeloid leukemia
- PVEK, a CD123-targeting ADC, is being evaluated as a monotx. for BPDCN & in combination with Vidaza (azacitidine) & Venclexta (venetoclax) for pts with untreated & r/r AML
Ref: AbbVie | Image: AbbVie | Press Release
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