The US Food and Drug Administration has approved lenvatinib (Lenvima) for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

The approval of lenvatinib was based on the demonstration of improved progression free survival (PFS) in a multicentre, double-blind, placebo-controlled trial (E7080-G00-303).

The trial enrolled 392 patients with locally recurrent or metastatic radioactive iodine-refractory differentiated thyroid cancer and radiographic evidence of disease progression within 12 months prior to randomisation.

Patients were randomised (2:1) to receive either lenvatinib 24 mg orally per day (n = 261) or matching placebo (n = 131).

Patients in the placebo arm were allowed to receive lenvatinib following independent radiologic confirmation of disease progression.

A statistically significant prolongation of PFS as determined by independent radiology review was demonstrated [HR 0.21 (95% CI: 0.16, 0.28); p < 0.001, stratified log-rank test].

Median PFS was 18.3 months in the lenvatinib arm and 3.6 months in the placebo arm.

Objective response rates were 65% and 2% in the lenvatinib and placebo arms, respectively.

No statistically significant difference in overall survival between the two arms was demonstrated.

Upon confirmation of progression, 109 (83%) patients randomly assigned to placebo received open-label lenvatinib.

The most common adverse reactions, in order of decreasing frequency, observed in the lenvatinib treated patients were hypertension, fatigue, diarrhoea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia (PPE) syndrome, abdominal pain, and dysphonia.

The most common serious adverse reactions were pneumonia (4%), hypertension (3%), and dehydration (3%).

Adverse reactions led to dose reductions in 68% of patients receiving lenvatinib and 18% of patients discontinued lenvatinib for adverse reactions.

The recommended dose of lenvatinib is 24 mg taken orally once daily.

Treatment should continue until disease progression or unacceptable toxicity/

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For more ecancer coverage of lenvatinib in the treatment of thyroid cancer, see the interview or press conference with Prof Martin Schlumberger.

Source: FDA