FDA Approves AbbVie Drug for Rare Blood Cancer Treatment

The FDA approved AbbVie's pivekimab sunirine-pvzy for a rare blood cancer. The drug targets the CD123 protein but carries a boxed warning for liver problems.

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The United States FDA approved ABBVIE INC's drug for a rare blood cancer on May 24, 2023, sending shares up more than 1% during afternoon trading. The treatment, pivekimab sunirine-pvzy, targets blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive cancer with few existing clinical options. This approval expands AbbVie's oncology portfolio into niche hematology markets where high unmet needs often command premium pricing.

BPDCN starts in immune cells and frequently spreads to the skin, bone marrow, and blood. Patients whose disease returns after initial treatment currently face extremely limited survival prospects. The FDA granted the drug priority review and orphan drug status to accelerate its availability for these patients.

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