The Community Focus Channel is supported with funding from Johnson & Johnson (Gold).
VJHemOnc is an independent medical education platform. Supporters, including channel supporters, have no influence over the production of content. The levels of sponsorship listed are reflective of the amount of funding given to support the channel.
ASCO 2026 | How the FDA approval of pivekimab sunirine may shape the field of BPDCN & advice for clinicians
Naveen Pemmaraju, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, comments on the recent FDA approval of pivekimab sunirine, a CD123-targeted agent, for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). He highlights how this approval is likely to shape the field and notes the importance of monitoring toxicities such as hepatotoxicity and peripheral edema when administering this agent. This interview took place during the 2026 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.
Transcript
So breaking news in our BPDCN field. Just this week, as we head into the ASCO meeting for 2026, we found out good news for our patients, caregivers, and families facing BPDCN. And that is the breaking news FDA US approval of the second of two drugs, Pivekimab sunirine, or we’ll call it PVEK, FDA approved for BPDCN. Now, this is also a CD123-targeted agent, so in the same superclass as the Tagraxofusp, from the earlier approval...
So breaking news in our BPDCN field. Just this week, as we head into the ASCO meeting for 2026, we found out good news for our patients, caregivers, and families facing BPDCN. And that is the breaking news FDA US approval of the second of two drugs, Pivekimab sunirine, or we’ll call it PVEK, FDA approved for BPDCN. Now, this is also a CD123-targeted agent, so in the same superclass as the Tagraxofusp, from the earlier approval. It has a different payload, a different linker, et cetera. Now, here with the PVEK, similar to the Tagraxofusp, it’s FDA-approved on the basis of a monotherapy, single oral clinical trial in this ultra-rare disease. And it did show high rates of CR, particularly in the frontline setting, and high rates of being able to successfully bridge to stem cell transplant. In the relapsed/refractory setting, it did show a number of remissions and responses, although more modest and more difficult, of course, than in the frontline setting for any of these agents. Finally, as with any new drug, with the excitement of an approval, we have to understand the toxicities and side effects. So with the PVEK, it’s a slightly different profile than prior drugs in this class. One is that of hepatotoxicity, which does have a black box US FDA warning. So that can include potentially VOD. So we need to monitor the liver tests. And then number two, a signal for peripheral edema. And then other toxicities, such as infusion-related reactions. So a brand new drug, it’s only given IV every three weeks. It can be administered outpatient. So it represents only the second ever CD123-approved targeted agent, so Tagraxofusp, but now PVEK. Both of the US for BPDCN. And again, the future directions, of course, will be the same. Combinations, what would work with these drugs. Two, what about the rate of central nervous system involvement, because these drugs presumably don’t cross the blood-brain barrier, so addition of lumbar puncture, IT chemo, other agents? And then three, can we expand the indications of these CD123-targeted drugs to other CD123-expressing tumors, such as, but not limited to, acute myeloid leukemia and others?
This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.
Read more...
