FDA Approves AbbVie’s DECNUPAZ for BPDCN

The U.S. Food and Drug Administration (FDA) has approved AbbVie’s DECNUPAZTM (pivekimab sunirine-pvzy) for the treatment of adult patients with BPDCN, an ultra-rare and aggressive hematologic malignancy with limited treatment options.

According to Roopal Thakkar, EVP, Research & Development, Chief Scientific Officer, AbbVie, “This approval delivers a new option for treating BPDCN and demonstrates our determination to drive meaningful advancements for patients affected by difficult-to-treat cancers.”

Patients with BPDCN often present with skin lesions, and the disease can rapidly spread to the bone marrow, lymph nodes, and central nervous system. The disease typically affects adult men aged 60-70 years. Despite initial treatment with intensive chemotherapy, which may include stem cell transplantation, many patients experience relapse, underscoring the need for new treatment options.

This approval was supported by the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of DECNUPAZ for BPDCN.

In CADENZA, DECNUPAZ showed meaningful, durable responses in newly diagnosed BPDCN. Among newly diagnosed patients (n=33), the composite complete response rate was 69.7% with a median response duration of 9.7 months; 13 patients (39.4%) went on to stem cell transplant. Among patients with relapsed or refractory disease (n=51), the composite complete response rate was 15.7% with a median response duration of 9.2 months; six patients (11.8%) went on to stem cell transplant.

The most common adverse reactions (≥20%) were edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. DECNUPAZ carries a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease, and warnings for infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity.

More AbbVie News

AbbVie recently began construction on two new active pharmaceutical ingredient (API) manufacturing facilities at its current North Chicago, Illinois, campus.