Ipsen Biopharmaceuticals Canada Inc. announced that Health Canada has approved CABOMETYX® (cabozantinib) for the treatment of adults with locally advanced or metastatic differentiated thyroid carcinoma (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory (RAI-R) or ineligible. CABOMETYX® was granted priority review for DTC by Health Canada because of the significant unmet need it fills for this patient population.
"Patients living with RAI-R DTC have limited treatment options, and often go without second line treatment even though they are well enough to receive one," said Dr. Sebastien Hotte, medical oncologist, the Juravinski Cancer Centre, Associate Professor, McMaster University. "The progression-free survival benefit demonstrated in the phase III COSMIC-311 trial means CABOMETYX® is of significant importance for patients I see every day. Thanks to this approval, patients who thought they had run out of options may have a chance for more time without disease progression."
It is estimated that 6,700 Canadians were diagnosed with thyroid cancer in 2021, with DTC accounting for up to 95% of cases. The incidence of thyroid cancer is three times higher in women than men and is the ninth most common cancer in the world. Most commonly treated with surgery, followed by ablation of the remaining thyroid tissue with RAI, approximately 5 to 15% of DTC cases become refractory to RAI treatment. Patients who develop RAI-refractory DTC have a poor prognosis with an average estimated survival of three to five years.
This approval is based on the Phase III COSMIC-311 trial, which demonstrated that CABOMETYX® showed statistically significant improvement in progression-free survival for patients vs placebo. In the primary analysis conducted after median follow-up of 6.2 months, CABOMETYX® was associated with a 78% reduction in risk of disease progression or death versus placebo (hazard ratio [HR]: 0.22; 96% confidence interval [CI]: 0.13-0.36; p>0.0001).
"We're proud to make new treatment options like CABOMETYX® available for patients suffering from DTC who previously had no other options after progression on a VEGF therapy," said Ed Dybka, General Manager, Ipsen Biopharmaceuticals Canada Inc. "With this approval, CABOMETYX® now has five indications, underscoring Ipsen's commitment to addressing unmet patient needs and the potential for CABOMETYX® to improve the lives of patients and their families."
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!