Cabozantinib (Cabometyx) has been granted approval by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for previously untreated patients who have intermediate- or poor-risk advanced renal cell carcinoma (RCC). The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
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.
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 appraisal committee meeting is taking place on 10th May 2018, and NICE guidance is expected to be published in October 2018. We will keep you updated on the progress of this appraisal.