The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cabometyx, intended for the treatment of advanced renal cell carcinoma ( RCC ).
Cabometyx is available as 20 mg, 40 mg and 60 mg film-coated tablets. The active substance of Cabometyx is Cabozantinib, a protein kinase inhibitor that inhibits multiple receptor tyrosine kinases implicated in tumour growth and angiogenesis, pathologic bone remodelling, drug resistance, and metastatic progression of cancer.
Cabometyx led to a statistically significant improvement in progression-free survival ( PFS ) compared with Everolimus: PFS was 7.4 months with Cabometyx versus 3.8 months with Everolimus [ HR=0.58 ( 0.45, 0.74 ), p less than 0.0001 ) ].
A planned interim analysis of overall survival ( OS ) was conducted at the time of the PFS analysis that did not reach the interim boundary for statistical significance ( HR=0.68 [ 0.51, 0.90 ], p=0.006 ).
In a subsequent unplanned interim analysis of overall survival, a statistically significant improvement was demonstrated for patients randomized to Cabometyx as compared with Everolimus ( median of 21.4 months vs 16.5 months; HR=0.66 [ 0.53, 0.83 ], p=0.0003.
The most common side effects are diarrhoea, fatigue, nausea, decreased appetite, palmar-plantar erythrodysaesthesia syndrome ( PPES ), hypertension, vomiting, weight decreased, and constipation.
The full indication is: Cabometyx is indicated for the treatment of advanced renal cell carcinoma ( RCC ) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. ( Xagena )
Source: EMA, 2016