The Committee for Medicinal Products for Human Use ( CHMP ) of EMA ( European Medicines Agency ) has adopted a positive opinion on Kisplyx for the treatment of patients with unresectable advanced or metastatic renal cell carcinoma ( RCC ).
Kisplyx is available as 4 mg and 10 mg hard capsules. The active substance of Kisplyx is Lenvatinib, a tyrosine kinase inhibitor that selectively inhibits the kinase activities of vascular endothelial growth factor ( VEGF ) receptors, in addition to other proangiogenic and oncogenic pathway-related receptor tyrosine kinases.
Kisplyx was shown to improve progression-free survival ( PFS ) in a randomized part of a phase Ib/II study when used with Everolimus ( median 14.6 [ 95% CI: 5.9-20.1 ] months ) compared with Everolimus used alone ( median 5.5 [ 95% CI: 3.5-7.1 ] months ) with a hazard ratio ( HR ) of 0.40 ( 95% CI: 0.24, 0.68; p less than 0.001 ).
The treatment effect of the combination was also supported by a post-hoc retrospective independent blinded review of scans with median PFS of 12.8 [ 95% CI: 7.4-17.5 ] months compared with Everolimus used alone ( median 5.6 [ 95% CI: 3.6-9.3 ] months ) with a HR of 0.45 ( 95% CI: 0.26, 0.79; p=0.003 ).
The most common side effects are diarrhoea, fatigue, decreased appetite, vomiting, nausea and hypertension. Severe diarrhoea occurred at a higher frequency in the combination group than in the Everolimus group.
The full indication is: Kisplyx is indicated in combination with Everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior VEGF-targeted therapy. ( Xagena )
Source: EMA, 2016