Italian Medicines Agency Approves Reimbursement for Cabozantinib Tablets in Treating Refractory Thyroid Cancer
The Italian Medicines Agency (AIFA) has granted approval for the reimbursement of cabozantinib tablets in the treatment of differentiated thyroid cancer that is refractory to radioactive iodine therapy. This decision comes following the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March 2022.
Cabozantinib tablets have been approved as monotherapy for adult patients with locally advanced or metastatic differentiated thyroid cancer that is refractory or ineligible for radioactive iodine, and have progressed during or after prior systemic therapy. The drug was made available to Italian patients under law 648/2020 starting from October 2021.
Differentiated thyroid carcinoma is commonly treated with surgery and radioactive iodine ablation, but approximately 5-15% of cases are resistant to radioiodine treatment. Patients who develop resistance have a poor prognosis, with an average survival of around three to five years.
The effectiveness of cabozantinib in treating refractory thyroid cancer was demonstrated in the COSMIC-311 study, which showed that the drug reduced the risk of disease progression or death by 78% compared to a placebo. This new treatment option offers hope for patients who do not benefit from other treatments, providing the possibility of gaining additional months or years of life.
Cabozantinib inhibits multiple tyrosine kinase receptors involved in cellular processes such as oncogenesis, metastasis, and tumor angiogenesis. The drug has now become a new standard of care for patients with refractory thyroid cancer who have not responded to previous treatments. In the COSMIC-311 study, the median progression-free survival with cabozantinib was 11 months, offering a significant benefit to patients in need of effective therapy.
The approval of cabozantinib as a second or third-line therapy represents a significant advancement in the treatment of patients with differentiated thyroid cancer who are resistant to radioiodine. This decision provides hope for those who have previously lacked a standard of care for their condition, offering a new lifeline in their fight against this challenging disease.