Kisplyx

Oncology· 136 cited findings· 1 source document

Company: Eisai Co., Ltd.

What the regulatory reviews say

Kisplyx is indicated in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one vascular endothelial growth factor (VEGF)-targeted prior therapy. The marketing authorization application for Kisplyx was submitted on 11 January 2016, with eligibility to the centralised procedure agreed on 21 May 2015 and acceptability of accelerated review agreed on 19 November 2015. A CHMP positive opinion was issued on 21 July 2016.

Efficacy findings for tumor growth inhibition (T/C value) included values of 26%, 0%, -20%, 2%, -23%, and -86%. The proposed daily dose of lenvatinib is 18 mg, and for everolimus, it is 5 mg. Safety data indicated hERG potassium current inhibition (IC50) at 11.89 μmol/L. Mortality rates in PND7 juvenile rats at 1 mg/kg lenvatinib were 7 out of 8/sex, and at 5 mg/kg lenvatinib, they were 8 out of 8/sex.

Key figures — cited to the source page

Tumor growth inhibition (T/C value)	26%	Kisplyx EMA EPAR public assessment report, p.25
Tumor growth inhibition (T/C value)	-86%	Kisplyx EMA EPAR public assessment report, p.25
hERG potassium current inhibition (IC50)	11.89	Kisplyx EMA EPAR public assessment report, p.27
Mortality rate in PND7 juvenile rats at 5 mg/kg lenvatinib	8 out of 8/sex	Kisplyx EMA EPAR public assessment report, p.44
Marketing authorization application submission date	11 January 2016	Kisplyx EMA EPAR public assessment report, p.7
CHMP positive opinion date	21 July 2016	Kisplyx EMA EPAR public assessment report, p.8
Proposed daily dose of lenvatinib	18	Kisplyx EMA EPAR public assessment report, p.12
Proposed daily dose of everolimus	5	Kisplyx EMA EPAR public assessment report, p.12

Source documents

Eisai Co., Ltd. — Kisplyx EMA EPAR public assessment report (EMEA/H/C/004224, 2016) (2016)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.