A supplemental New Drug Application for Cabometyx (cabozantinib) was granted FDA priority review as a treatment for patients 12 years and older with differentiated thyroid cancer who have progressed following prior therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate).
Cabometyx is sponsored by Exelixis Inc.
The FDA granted Priority Review designation and assigned a Prescription Drug User Fee Act target action date of Dec. 4, 2021.
The sNDA is based on the results of COSMIC-311, a phase III pivotal trial evaluating Cabometyx versus placebo in patients with radioactive iodine-refractory DTC who progressed after up to two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies.
At a planned interim analysis, Cabometyx met one of the trial’s primary endpoints, demonstrating a significant improvement in progression-free survival versus placebo.
In February 2021, the FDA granted Breakthrough Therapy Designation to Cabometyx as a potential treatment for patients with DTC that has progressed following prior therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) based on these results. Detailed study findings were presented at the 2021 American Society of Clinical Oncology annual meeting and were published by The Lancet Oncology in July 2021.