Obtained FDA approval two and a half months ahead of schedule for multi-kinase inhibitors to obtain new indications

Exelixis announced today that the US FDA has approved cabozantinib (cabozantinib, English trade name Cabometyx) for extended indications for the treatment of locally advanced or metastatic differentiated thyroid cancer (DTC) adults and children over 12 years of age
.

For this indication, Cabometyx has obtained breakthrough therapy designation and priority review qualifications, and the approval time was more than two months earlier than the target PDUFA day (December 4)
.

Cabozantinib is an oral small molecule tyrosine kinase inhibitor that can inhibit the activities of c-Met, VEGFR2, and AXL and RET
.

This approval is based on the positive results obtained from the pivotal Phase 3 clinical trial COSMIC-311
.

Cancerous thyroid tumors include differentiated, medullary, and undifferentiated types.
Differentiated thyroid tumors account for about 90% of cases, including papillary, follicular, and Hürthle cell carcinomas
.

Reference materials:

[1] Exelixis Announces US FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer.