FDA Approves Lusutrombopag for Thrombocytopenia in Adults With Chronic Liver Disease
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®.
