FDA Approves Beleodaq (belinostat) for Type of T-cell Lymphoma

The US Food and Drug Administration (FDA) has approved Beleodaq (belinostat) for people with peripheral T-cell lymphoma who did not get better after treatment with other drugs, or whose cancer came back after treatment with other drugs. There are many types of peripheral T-cell lymphoma, a type of lymph node cancer.

Beleodaq was approved under the FDA’s accelerated approval program for drugs that show promise against a serious disease. The company that makes the drug must submit additional clinical information after approval, to demonstrate its benefit.

The approval was based on a study of 129 people with peripheral T-cell lymphoma that did not improve with treatment or came back after treatment. All the participants were given Beleodaq and 25.8% of them improved; their cancer either shrank or disappeared.

The drug is given through intravenous infusion. The most common side effects among participants in the study were nausea, vomiting, fatigue, fever, and low red blood cells (anemia). Rare, but serious side effects included bleeding problems, pneumonia, infection, and organ failure.

Beleodaq is marketed by Spectrum Pharmaceuticals, Inc.

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