Exelixis's Cabometyx Scores FDA Nod In Differentiated Thyroid Cancer; ESMO Presentation

The FDA has approved Exelixis Inc's EXEL Cabometyx (cabozantinib) for thyroid cancer in patients aged 12 years and older.
The approval covers patients with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible.
The nod comes more than two months ahead of the Prescription Drug User Fee Act (PDUFA) target action date of December 4.
Related content: Benzinga's Full FDA Calendar.
Separately, Exelixis announced final results from the phase 3 COSMIC-311 trial of Cabometyx in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer (DTC).
The data were presented at the European Society for Medical Oncology Congress (ESMO21) 2021.
At a median follow-up of 10.1 months, the significant improvement in progression-free survival (PFS) with Cabometyx was maintained, with consistent benefit in subgroups based on prior treatment.
The Median PFS was 11.0 months for patients treated with Cabometyx (n=170) compared with 1.9 months in the placebo arm.
Updated analysis for the primary endpoint of objective response rate (ORR) favored Cabometyx at 11%, including one complete response, versus 0% for placebo.
Median overall survival, an additional endpoint, was 19.4 months for patients treated with Cabometyx and not estimable for patients treated with placebo.
Price Action: EXEL shares are down 4.97% at $19.69 during the market session on the last check Monday.
Check out our coverage of the European Society for Medical Oncology Congress (ESMO21).

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