AbbVie Submits Biologics License Application (BLA) to U.S. FDA for Pivekimab sunirine (PVEK) - an Investigational Antibody-Drug Conjugate (ADC) to Treat Rare Cancer with Limited Treatment Options

– BLA based on data from the global Phase 1/2 CADENZA trial

NORTH CHICAGO, Ill., Sept. 30, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced submission of a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of investigational Pivekimab sunirine (PVEK) for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). The submission is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN. BPDCN is a rare and aggressive blood cancer that has features of both leukemia and lymphoma. Patients typically present with skin lesions and the disease often spreads to the bone marrow, central nervous system and the lymph nodes. First-line treatments are typically intensive chemotherapy and often followed by stem cell transplant. The need for additional and innovative treatment is high for both newly diagnosed patients and for those whose prior treatments have resulted in relapsed or refractory disease.

PVEK is a CD123-targeting Antibody-Drug Conjugate (ADC) in clinical development for hematological malignancies (blood cancers), including BPDCN and acute myeloid leukemia (AML). ADCs are designed to deliver potent cancer cell death-inducing agents called 'payloads' directly to the cancer cells expressing a specific protein. CD123 (IL-3Rα) is a protein overexpressed in BPDCN, making it an ideal target for therapy.

"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," said Roopal Thakkar, executive vice president, research and development and chief scientific officer, AbbVie. "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)."

About the CADENZA Trial

CADENZA is a Phase 1/2 multicenter, open-label study designed to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing schedule for PVEK monotherapy and to assess the safety, tolerability, PK, immunogenicity, and antileukemia activity of PVEK when administered to subjects with CD123+ hematologic malignancies (including subjects with BPDCN, AML, and others).

About Pivekimab Sunirine (PVEK)

PVEK is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML). PVEK is currently being evaluated as monotherapy for patients with BPDCN and in combination with Vidaza^® (azacitidine) and Venclexta^® (venetoclax) for patients with untreated and relapsed/refractory AML. In October 2020, the FDA granted PVEK Breakthrough Therapy designation in relapsed/refractory BPDCN.

About AbbVie in Oncology

AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.

Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

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SOURCE AbbVie