eisa0001

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

Related Content

shutterstock_273326141

Eisai and Wren Therapeutics join forces to tackle neurodegenerative synucleinopathies

Eisai has forged an exclusive research partnership with Wren Therapeutics to develop new approaches in …

shutter

Japan approves Gilead and Eisai’s Jyseleca for rheumatoid arthritis

Gilead and Eisai have secured approval for their oral JAK1 preferential inhibitor Jyseleca (filgotinib) from …

shutterstock_38078521

New Lenvima/Keytruda combo data in a range of cancers presented at ESMO 2020

New data from two studies investigating the combination of Eisai’s multiple receptor tyrosine kinase inhibitor …

Latest content