EU approval for Eisai kidney cancer treatment

pharmafile | September 15, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Afinitor, Eisai, Kisplyx, Lenvima, everolimus 

The European Commission has approved the use of Eisai’s Kisplyx (lenvatinib) for the treatment of renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF) targeted therapy, when used in combination with everolimus (Novartis’ Afinitor).

This marks the second region the treatment has been licensed in for tackling the advanced kidney cancer after the US. The drug is an oral molecular tri-specific targeted therapy with potent selectivity, and already available in Europe for treatment of progressive, locally advanced or metastatic differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma, refractory to radioactive iodine under the tradename Lenvima.

The decision was based on results of a Phase II study that found that patients treated with lenvatinib plus everolimus demonstrated a significant extension in the study’s primary endpoint of progression free survival (PFS) compared to those treated with everolimus alone. Additionally, updated median overall survival was 25.5 months in the lenvatinib plus everolimus group compared with 15.4 months in the everolimus alone group.

Renal cell carcinoma affects approximately 338,000 worldwide, accounting for more than 90% of all malignancies of the kidney.

Matt Fellows

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