(Corrects to clarify the total number of patients in the study in paragraph 10)
May 27 (Reuters) – The U.S. Food and Drug Administration on Wednesday approved AbbVie’s drug to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN), a very rare type of blood cancer.
AbbVie’s shares were up more than 1% in afternoon trading.
The approval provides a new treatment option in a setting with limited choices, particularly for patients whose disease has returned or did not respond to earlier treatment.
The drug, pivekimab sunirine‑pvzy, is given through a vein once every three weeks.
The FDA said the drug carries a boxed warning for serious liver problems, including a condition where blood flow in the liver is blocked.
The agency also flagged risks such as reactions during infusion and fluid buildup in the body.
BPDCN is a rare and aggressive cancer that starts in certain immune cells and can spread to the skin, bone marrow and blood.
Patients often have limited treatment options, particularly if the disease returns after treatment.
AbbVie’s pivekimab sunirine‑pvzy targets a protein called CD123 commonly found on these cancer cells and delivers a cancer‑killing agent directly to them.
In a study involving a total of 84 patients, 23 out of 33 previously untreated patients saw their cancer disappear, while 8 of 51 patients whose disease had returned or did not respond to earlier treatment achieved similar results.
Patients who responded to the treatment remained free of disease for several months, with responses lasting a median of about nine months in both groups, the FDA said.
The drug was reviewed under the FDA’s priority review and received breakthrough and orphan drug designations, programs aimed at speeding up development of treatments for serious conditions with limited options.
(Reporting by Sahil Pandey in Bengaluru; Editing by Shreya Biswas)
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