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NICE backs EUSA's RCC treatment Fotivda

The UK’s cost-effectiveness watchdog recommends its first-line use

EUSAEUSA Pharma has won NICE backing for Fotivda (tivozanib) as a first-line treatment for advanced renal cell carcimona (RCC).

The recommendation from the UK’s cost-effectiveness watchdog came on the back of the phase III trial TiVO-1, which evaluated the efficacy and tolerability of Fotivda compared to Bayer’s Nexavar (sorafenib).

It showed patients treated with EUSA’s drug experienced a superior progression-free survival of 11.9 months verses Nexavar (9.1 months) and an improved side effect profile, with only 14% of patients on Fotivda requiring a dose reduction due to adverse events compared to the 43% on Nexavar.

Lee Morley, chief executive officer for EUSA Pharma, said: “We are very pleased that NICE are recommending the use of Fotivda for the first-line treatment of advanced renal cell carcinoma and that Fotivda will be funded immediately in England and Wales.

“Fotivda has the potential to become an important new first-line therapy and the recommendation by NICE is a great achievement for the EUSA team delivering on their mission to improve the lives of those patients suffering from cancer.”

According to Cancer Research UK, around 12 people in the UK die every day of kidney cancer, with RCC being the most common form of kidney cancer, accounting for 80% of cases.

EUSA licenced Fotivda from Aveo Pharmaceuticals back in 2015, but although it has European approval in advanced renal cell carcinoma it failed to gain approval from the US Food and Drug Administration (FDA) in 2013. However, Aveo Oncology is looking to re-file Fotivda in the US pending the results of the TIVO-3 study.

Article by
Gemma Jones

12th February 2018

From: Regulatory

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