AbbVie (NYSE: ABBV) announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its experimental asset, Pivekimab sunirine (PVEK), marking a significant advancement in the treatment of a rare and aggressive form of blood cancer. The approval of the antibody-drug conjugate (ADC) is being pursued in order to treat Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), a deadly cancer for which there are currently very few available therapeutic options.
As the company’s first-ever BLA for an antibody-drug conjugate in blood cancer, the submission represents a significant turning point in AbbVie’s growing oncology portfolio.
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A Breakthrough Target for a Rare Disease
A powerful payload that kills cancer cells directly while preserving healthy tissue is delivered to cancerous cells using PVEK, an experimental antibody-drug conjugate (ADC), a type of targeted therapy. PVEK is a perfect therapeutic target because it selectively targets the CD123 protein, which is markedly overexpressed in BPDCN cells.
Often presenting with painful skin lesions, BPDCN is an aggressive hematologic malignancy (blood cancer) that progresses quickly to the lymph nodes, bone marrow, and central nervous system. A substantial unmet medical need exists for both newly diagnosed and relapsed/refractory patients, as current first-line treatments usually include severe chemotherapy followed by a stem cell transplant.
The effectiveness and safety findings from the international Phase 1/2 CADENZA study, which assessed PVEK as a monotherapy for BPDCN, serve as the foundation for the BLA filing.
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Significance and Regulatory Path
Meaningful innovations in cancer research and treatment are happening every day. It is important that these innovations reach patients who desperately need them, including those with rare cancers who have limited options,
We look forward to next steps in the regulatory process for our latest Antibody-Drug Conjugate (ADC), our first ADC in blood cancer, and how it may advance treatment for those living with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN).
Roopal Thakkar
GSK Secures Japan Orphan Drug Designation for Risvutatug Rezetecan in Small-Cell Lung Cancer
GSK’s risvutatug rezetecan has officially secured Orphan Drug Designation from Japan’s MHLW for the treatment of small-cell lung cancer (SCLC). Supported by durable response data […]
In order to speed up the research and review of medications for critical or life-threatening illnesses, the FDA acknowledged the potential of this therapy earlier in October 2020 when it designated PVEK Breakthrough Therapy for the treatment of relapsed or refractory BPDCN.
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Graduated from the University of Kerala'20 with B.Sc. Botany & Biotechnology. Post-graduation in Biotechnology from the University of Kerala'22. Internship experience in Cancer Research.
