Eisai submits new cancer combo to EMA for approval

pharmafile | January 12, 2016 | News story | Sales and Marketing Afinitor, EMA, Eisai, Lenvima, MAA, Novartis, everolimus, lenvatinib 

Eisai has submitted a new Marketing Authorisation Application to the EMA for the combination of Lenvima and Novartis’ Afinitor for the treatment of unresectable advanced or metastatic renal cell carcinoma. 

Lenvima (lenvatinib) was approved after an accelerated assessment in Europe by the EMA in October 2015. Eisai has already submitted an application for the combo to the US FDA. Lenvima was launched in the US for the treatment of thyroid cancer in March 2015.  

The new application is based on a Phase II trial of Lenvima, which when used in combination with Afinitor (everolimus), showed progression-free survival was significantly extended in people with metastatic renal cell carcinoma (mRCC) compared with people treated with Afinitor alone. People treated with the combination regimen experienced a median progression-free survival of 14.6 months compared with 5.5 months for those who received everolimus alone. 

“The Phase II data showed that, for people with metastatic kidney cancer, the addition of lenvatinib offered a statistically significant progression free survival benefit compared to everolimus alone. The news that Eisai has submitted this application is hugely positive, for both clinicians and patients alike. The current outlook for people with this aggressive cancer is poor, and therefore the potential of lenvatinib is very exciting indeed,” comments Dr Hilary Glen, consultant medical oncologist, Beatson West of Scotland Cancer Centre, Scotland, UK. 

Renal cell carcinoma is the most common form of kidney cancer. The standard treatment for unresectable advanced or metastatic renal cell carcinoma is molecular targeted drug therapy, which is designed to interfere with the specific molecules necessary for tumour growth and progression. Despite this, it remains a disease for which patients have very few treatment options. 

Gary Hendler, president and chief executive of Eisai EMEA and president of the Eisai oncology global business unit, says: “This submission is very important for clinicians, patients and Eisai. The development of lenvatinib was only possible with the support of so many pioneering scientists who have worked in this complex area of medicine for years. We are honoured to submit this application and hope that patients in Europe will not have to wait long before accessing the treatment.” 

AbbVie and Genentech submit FDA application

In the US, the FDA has granted Genentech, an arm of Roche, a priority review of its new drug application for venetoclax as a treatment for people with chronic lymphocytic leukemia (CLL). Venetoclax was granted Breakthrough Therapy Designation by the FDA in April 2015 for the treatment of people with previously treated (relapsed or refractory) CLL with 17p deletion – in a joint venture with AbbVie.

“Venetoclax is a potential new way to treat this difficult type of chronic lymphocytic leukemia,” says Sandra Horning, chief medical officer and head of global product development. “We look forward to working with AbbVie and health authorities to bring this first-of-its-kind medicine to people who need more options.”

Joel Levy 

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