Exelixis's Cabometyx Scores FDA Nod In Differentiated Thyroid Cancer; ESMO Presentation
- The FDA has approved Exelixis Inc's (NASDAQ: 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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