by Health Editorial Staff
The Italian Medicines Agency has granted reimbursement to a drug in tablets that can help patients with locally advanced or metastatic differentiated thyroid cancer gain months or years of life
The Italian Medicines Agency (AIFA) has approved the reimbursement of cabozantinib tablets for the treatment of differentiated thyroid cancer that is refractory, i.e. that does not respond, to radioactive iodine therapy.
The Italian approval follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the EMA (European Medicines Agency) in March 2022, relating to the use of cabozantinib tablets as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer, refractory or ineligible for radioactive iodine, which have progressed during or after prior systemic therapy.
The drug, in consideration of the important unmet clinical need and the added therapeutic value, was made available to Italian patients through law 648/2020 starting from October 2021.
Differentiated carcinoma refractory to radioiodine
Globally, there are over 580 thousand new cases of thyroid cancer per year, the incidence of which is three times higher in women than in men. There are several types of thyroid cancer (differentiated, medullary, and anaplastic), but differentiated thyroid cancers (which in turn include papillary, follicular, and Hürthle cell forms) account for approximately 90-95% of cases.
«Differentiated thyroid carcinoma is commonly treated with surgery, followed by radioactive iodine ablation of the residual thyroid tissue, but approximately 5-15% of cases are resistant to radioiodine treatment – explains Rossella Elisei, President of the Italian Thyroid Association ( AIT) -. Patients who develop resistance have a poor prognosis with an average survival of around three to five years.”
Gain months or years of life
The effectiveness of the new treatment emerges from the results of the COSMIC-311 study, which enrolled 258 patients in 164 centers globally and demonstrated how cabozantinib is able to reduce the risk of disease progression or death by 78% compared to placebo.
«The approval of the reimbursement of cabozantinib for “complex” patients with an advanced stage of cancer, who do not benefit from other treatments and who progress during first-line systemic medical therapy is an important result – comments Elisei -. The true meaning is to have another therapeutic weapon available for these patients, who will thus be able to gain additional months and years of life. Cabozantinib has already proven useful for its ability to stop the growth of medullary thyroid carcinoma, this new approval from Aifa will allow it to be used in an equally important context from a clinical point of view.”
New standard for patients who did not have an effective treatment
Cabozantinib is an orally administered small molecule that inhibits multiple tyrosine kinase receptors such as VEGFR, MET, RET and the TAM family (TYRO3, MER, AXL). These tyrosine kinase receptors are involved in normal and pathological cellular processes, such as oncogenesis, metastasis, tumor angiogenesis (the growth of new blood vessels that tumors need to grow), drug resistance, modulation of immune activities and maintenance of the tumor microenvironment. «The approval of cabozantinib as a 2nd/3rd line therapy is a fundamental step forward in the treatment of patients with differentiated thyroid cancer, radio-iodine resistant, in progression after a first line of treatment – concludes Laura Locati, director of Oncology at the Maugeri Scientific Clinical Institutes, IRCCS of Pavia and associate professor of Medical Oncology at the University of Pavia -. The effectiveness of cabozantinib was tested in a randomized study in which the drug was shown to reduce the probability of progression of thyroid cancer by 78% compared to placebo, thus responding to a specific need for treatment for which, to date , there was no standard of care yet. In the COSMIC-311 study the median progression-free survival was 11 months.”
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March 6, 2024
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