Express was approved by the FDA two and a half months ahead of schedule, and multi-kinase inhibitors gained new indications

▎Exelixis, editor of WuXi AppTec’s content team, 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 12 Patients over the age of children
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These patients progressed after receiving VEGFR-targeted therapy, and were not suitable for radioiodine therapy or developed resistance to it
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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)
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Cabozantinib is an oral small molecule tyrosine kinase inhibitor that can inhibit the activities of c-Met, VEGFR2, and AXL and RET
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This approval is based on the positive results obtained from the pivotal Phase 3 clinical trial COSMIC-311
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At a median follow-up time of 10.
1 months, the median progression-free survival (PFS) of the cabozantinib group was 11.
0 months and that of the placebo group was 1.
9 months (HR=0.
22, 95% CI: 0.
15-0.
31 )
.

The specific results will be announced at the ongoing ESMO conference
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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
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The standard treatment for differentiated thyroid cancer is surgery first, followed by ablation of the remaining thyroid tissue with radioactive iodine, but about 5% to 15% of patients show resistance to radioactive iodine therapy
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For these patients, the life expectancy from the discovery of metastatic lesions is only 3-5 years, so there is a high degree of unmet medical needs
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"Previously, patients with radioactive iodine resistance who received VEGFR-targeted therapy would have no standard treatment options if the disease continues to progress
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" said Dr.
Marcia S.
Brose from Thomas Jefferson University, the lead investigator of the Phase 3 clinical trial .
"The FDA approval of Cabometyx is a major advancement for these patients who urgently need new treatment options
.

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