The FDA has granted Breakthrough Therapy Designation to cabozantinib for the potential treatment of patients with differentiated thyroid cancer that has progressed following prior therapy and who are radioactive iodine-refractory if eligible for radioactive iodine.
Gallium-68 prostate-specific membrane antigen PET imaging demonstrated the ability to detect metastatic thyroid cancer but resulted in a lower detection rate compared with 2-[18F]FDG PET for thyroid cancer lesion visualization.
Patients with tissue tumor mutational burden-high solid tumors represent a subset of patients who could have a robust tumor response to the immune checkpoint inhibitor pembrolizumab as monotherapy, suggesting tTMB may be a novel and useful predictor of response in patients with previously treated recurrent or metastatic advanced solid tumors, including thyroid cancer.
Cabozantinib demonstrated significant improvement in progression-free survival in patients with radioiodine-refractory differentiated thyroid cancer who have progressed after up to 2 prior vascular endothelial growth factor receptor-targeted therapies compared with placebo, meeting the primary end point of the pivotal phase 3 COSMIC-311 clinical trial.
The FDA approved pralsetinib for the treatment of adult and pediatric patients who are 12 years old or older with advanced or metastatic RET-mutant medullary thyroid cancer and require systemic therapy.