ABBV News & Events

Allergan Aesthetics, an AbbVie company, announced the U.S. FDA approval of Skinvive by Juvederm to reduce neck lines for the improvement of neck appearance in adults over the age of 21. With this approval, Skinvive by Juvederm is the first and only hyaluronic acid injectable indicated to reduce the appearance of neck wrinkles and help skin retain its natural moisture, leading to an improved neck appearance.

AbbVie announced new Phase 3 data on a fixed-duration venetoclax-based combination at the European Hematology Association, or EHA, 2026 Congress taking place June 11-14 in Stockholm, Sweden. Final results from the Phase 3 CLL14 trial in previously untreated chronic lymphocytic leukemia, which was conducted in collaboration with the German CLL Study Group, will be featured in an oral presentation. A final analysis of the Phase 3 CLL14 trial, conducted in close collaboration with the German CLL Study Group, comparing venetoclax plus obinutuzumab to chlorambucil plus obinutuzumab in previously untreated patients with CLL and coexisting medical conditions, found that venetoclax plus obinutuzumab significantly improved progression-free survival compared to chlorambucil plus obinutuzumab, providing a limited-duration treatment option for unfit patients with previously untreated CLL. The nine-year analysis demonstrated the long-term off-treatment efficacy and safety of the venetoclax plus obinutuzumab fixed-duration combination, with the median time to next treatment of 7.6 years. After a median follow-up of 9.2 years, treatment with venetoclax plus obinutuzumab resulted in superior PFS compared to the obinutuzumab plus chlorambucil group, with median PFS of 6.4 years versus 3.2 years, respectively. The most frequently occurring Grade 3 adverse events, or AEs, in patients receiving the venetoclax-based combination were neutropenia, thrombocytopenia, infusion-related reaction, anemia, febrile neutropenia, pneumonia and leukopenia.

AbbVie announced that the European Commission has authorized an expanded label for Venclyxto to include use in combination with acalabrutinib and use in combination with ibrutinib for the treatment of adult patients with previously untreated chronic lymphocytic leukemia. The expanded label follows the EC's inclusion of these combinations in the acalabrutinib and ibrutinib labels. These all-oral, fixed-duration combination regimens support current standards of care and offer patients and providers additional targeted oral medications for CLL in the first-line setting that include the potential for time off treatment. The European Commission authorization extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein.

AbbVie "announced that the FDA has approved DECNUPAZ- pivekimab sunirine-pvzy - for the treatment of adult patients with BPDCN, an ultra-rare and aggressive hematologic malignancy with limited treatment options. The approval is supported by data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of DECNUPAZ for BPDCN. 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 60-70years. Despite initial treatment with intensive chemotherapy, which may include stem cell transplantation, many patients experience relapse, underscoring the need for new treatment options. In the Phase 1/2 CADENZA trial, newly diagnosed patients with BPDCN who were treated with DECNUPAZ demonstrated clinically meaningful and durable responses. In newly diagnosed patients with BPDCN, researchers observed a composite complete response rate of 69.7% with a median duration of response of 9.7 months, with 13 patients who were able to receive post-study treatment stem cell transplant. Patients with relapsed or refractory disease had a composite complete response rate of 15.7% with median duration of response rate of 9.2 months, with six patients who were able to receive post-study treatment stem cell transplant."