WASHINGTON, D.C. — The FDA on Wednesday granted full approval to the drug selpercatinib, marketed as Retevmo, for treating advanced thyroid cancer in both adults and children aged 2 and older. This approval covers patients with RET fusion-positive thyroid cancer who need systemic therapy and do not respond to radioactive iodine treatment.
Retevmo had previously received accelerated approval for patients aged 12 and older in 2020. The drug is now fully approved, based on comprehensive clinical trial data.
The clinical trial, LIBRETTO-001, involved 65 patients with RET fusion-positive thyroid cancer who did not respond to radioactive iodine. These patients were divided into two groups: those who had never received systemic therapy and those who had been previously treated.
Results from the trial showed a high effectiveness of the drug. In patients who had been previously treated, 85% responded to the treatment, with the response lasting a median of 26.7 months. For those who had not received prior systemic therapy, the response rate was even higher at 96%.
The approval also considered additional data from another clinical trial, LIBRETTO-121, which focused on pediatric and young adult patients with advanced RET-altered tumors. In this study, 60% of patients responded to the treatment, and 83% had a response lasting at least 12 months.
Common side effects of Retevmo include edema (swelling), diarrhea, fatigue, dry mouth, high blood pressure, abdominal pain, constipation, rash, nausea, and headache. Serious laboratory abnormalities included decreased lymphocyte levels, increased liver enzymes (ALT and AST), and reduced levels of sodium and calcium.
The dosage of Retevmo varies by age and weight. For children aged 2 to under 12, the dose is based on body surface area. For patients aged 12 and older, it is based on weight. Detailed dosing information is available in the prescribing instructions.
This full approval marks a significant advancement in the treatment of advanced thyroid cancer, offering hope to patients who previously had limited options.
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