AbbVie Files FDA Approval for Rare Blood Cancer Therapy

AbbVie has forwarded a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) that aims to get consent for an experimental treatment, Pivekimab sunirine (PVEK) for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), the latter being a rare and extremely aggressive hematologic malignancy.

The global phase 1/2 CADENZA trial, which studied PVEK's safety and effectiveness in patients with therapy-resistant blood cancer, data forming the basis for this application, is the main contributor to the submission.

BPDCN is a disease that features aspects of both leukemia and lymphoma; consequently, initially, patients most often have skin lesions with the disease progressing to bone marrow, lymph nodes, and the central nervous system.

Stage disease is usually treated by intensive chemotherapy, sometimes followed by a stem cell transplantation, but the secondary diseases are much more difficult to cure; thus, these patients are in need of new solutions. Hence, the call for a breakthrough therapy is becoming louder and more urgent.

Also Read: Fujifilm India Launches DR X-ray Facility to Boost Healthcare

PVEK is a CD123-targeting Antibody-Drug Conjugate (ADC) aimed at the direct on-site delivery of a powerful anticancer payload to cancer cells that express CD123, a protein that is significantly overexpressed in BPDCN, thus the most ideal target. Besides this, the drug is also considered for patients with blood cancer, namely AML.

“Patients with rare cancers and limited treatment options necessitate the introduction of groundbreaking innovations in cancer therapy,” said Roopal Thakkar, AbbVie Executive Vice President, Research & Development, and Chief Scientific Officer. “By submitting this BLA, we are one step closer to giving BPDCN patients the gift of novel treatment options. Pivekimab sunirine is our first ADC in hematologic malignancies and we eagerly await the regulatory review process.”