Onco-Summaries: Daily Oncology Updates at a Glance

30/09/2025

Umoja Biopharma's UB-VV111 in vivo CAR T cell therapy received the FDA fast track designation for B-Cell Malignancies (Ref)

The US FDA granted the fast track designation to Umoja Biopharma's UB-VV111 (off-the-shelf drug product that generates CD19-directed CAR T cells in vivo) for the treatment of relapsed/refractory Large B-cell Lymphoma following two or more lines of prior therapy and relapsed/refractory Chronic Lymphocytic Leukemia following two or more lines of prior therapy.

• A Phase 1 NCT06528301 trial is ongoing to evaluate the safety and antitumor activity of UB-VV111 in CD19+ B-cell malignancies

  
  

• To note, AbbVie retains an exclusive option to license Umoja’s CD19-directed in vivo CAR T cell therapy candidates, including UB-VV111

AbbVie submitted a BLA to the FDA for pivekimab sunirine for the Tx of BPDCN (Ref)

AbbVie completed the submission of a new BLA to the US FDA for approval of pivekimab sunirine (CD123-targeting ADC) for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN).

• The submission is based on results from the Phase 1/2 CADENZA trial

  
  

• Roopal Thakkar, Executive Vice President, Research and Development and CSO, AbbVie: "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)."