Exelixis announced that the Food & Drug Administration (FDA) has granted Breakthrough Therapy designation to cabozantinib as a potential treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.

Cabozantinib received Breakthrough Therapy designation based on the results of the Phase 3 METEOR trial comparing cabozantinib to everolimus in patients with RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI). METEOR met its primary endpoint, demonstrating a statistically significant increase in progression-free survival (PFS) for cabozantinib as compared to everolimus in the first 375 patients randomized. Cabozantinib reduced the rate of disease progression or death by 42% compared to everolimus (hazard ratio [HR]=0.58, 95% confidence interval [CI] 0.45-0.75, P<0.0001).

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Cometriq (cabozantinib capsules) is currently approved by the FDA for the treatment of progressive, metastatic medullary thyroid cancer (MTC). A distinct tablet formulation is under investigation for advanced RCC and other types of cancer.

Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGF receptors, AXL, and RET.

For more information call (650) 837–7000 or visit Exelixis.com.