USFDA Clears AbbVie's Pivekimab for Rare Blood Cancer Treatment

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 of 33 previously ‌untreated patients, about 70% saw their cancer disappear, while about 16% 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.