CABOMETYX (Ipsen Pty Ltd)
Product name
CABOMETYX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
213 (255 working days)
Active ingredients
cabozantinib (S)-malate
Registration type
EOI
Indication
Differentiated Thyroid Carcinoma (DTC)
CABOMETYX is indicated as monotherapy for the treatment of adult and paediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid carcinoma (DTC) that has progressed during or after prior VEGFR-targeted therapy and who are radioactive iodine (RAI) refractory or ineligible.