FDA Approves Cabometyx for First-Line Treatment of Advanced RCC

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Treatment with cabozantinib led to a clinically meaningful improvement in progression-free survival compared with sunitinib.
Treatment with cabozantinib led to a clinically meaningful improvement in progression-free survival compared with sunitinib.

Exelixis announced that the Food and Drug Administration (FDA) has approved Cabometyx (cabozantinib) as first-line treatment for patients with advanced renal cell carcinoma (RCC).

The FDA's expanded approval was supported by data from the Phase 2 CABOSUN trial (n=157) in patients with previously untreated RCC. In the study, treatment with cabozantinib led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with sunitinib. Moreover, treatment with cabozantinib was associated with a 52% reduction in the rate of disease progression or death (hazard ratio [HR] 0.48, 95% CI: 0.31-0.74; P=0.0008). The median PFS was higher in the cabozantinib group vs sunitinib group (8.6 months vs 5.3 months), which translated to a 3.3 month (62%) improvement. 

Regarding safety, hypertension, diarrhea, hyponatremia, hypophosphatemia, palmar-plantar erythrodysesthesia (PPE), fatigue, increased ALT, decreased appetite, stomatitis, pain, hypotension, and syncope were the most frequent all-cause Grade 3-4 adverse reactions (at least 5%) in patients treated with cabozantinib.

Cabometyx, a kinase inhibitor, was initially approved in 2016 for the treatment of advanced RCC in patients who had previously received anti-angiogenic therapy. It is available as 20mg, 40mg, and 60mg strength tablets.

For more information call (650) 837-7000 or visit Cabometyx.com.

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