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FDA Approves Lusutrombopag for Thrombocytopenia in Adults With Chronic Liver Disease

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Today, the U.S. Food and Drug Administration (FDA) approved lusutrombopag (Mulpleta) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.

L-PLUS 1 and L-PLUS 2

Approval was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2) involving 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure and had a platelet count less than 50 x 109/L. Patients were randomized 1:1 to receive 3 mg of lusutrombopag or placebo once daily for up to 7 days.

In L-PLUS 1, 78% of patients (38 of 49) receiving lusutrombopag required no platelet transfusion prior to the primary invasive procedure, compared with 13% (6 of 48) who received placebo (95% confidence interval [CI] for treatment difference = 49%–79%; P < .0001). In L-PLUS 2, 65% (70 of 108) of patients who received lusutrombopag required no platelet transfusion prior to the primary invasive procedure or rescue therapy for bleeding from randomization through 7 days after the procedure, compared with 29% (31 of 107) receiving placebo (95% CI = 25%–49%; P < .0001).
The most common adverse reaction in ≥ 3% of patients was headache.

The recommended lusutrombopag dosage is 3 mg orally once daily with or without food for 7 days.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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