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Cabozantinib (Cabometyx) has been granted approval by the US Food and Drug Administration (FDA) for previously untreated patients who have advanced renal cell carcinoma (RCC). The approval is based on data from the phase 2 CABOSUN trial, that showed improvements in progression-free survival (PFS) for patients on cabozantinib compared to those who were given sunitinib (Sutent).
In the CABOSUN study, first-line treatment with cabozantinib reduced the risk of progression or death by 52% compared with sunitinib for patients with advanced RCC. The median PFS was 8.6 months with cabozantinib versus 5.3 months for sunitinib. The approval was granted approximately two months ahead of an FDA deadline.
In England and Wales, the National Institute for Health and Care Excellence (NICE) is currently appraising the use of cabozantinib for previously untreated patients with advanced RCC. The NICE guidance is expected to be published in October 2018. We will keep you updated on the progress of this appraisal.