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NICE clears Ipsen’s Cabometyx in first-line kidney cancer

Drug increased PFS by 2.6 months compared to Pfizer’s Sutent

Ipsen

The UK’s cost-effectiveness watchdog NICE has recommended first-line use of Ipsen’s Cabometyx for treatment-naïve patients with advanced renal cell carcinoma (RCC), the most common form of kidney cancer.

Cabometyx is already available as second-line use, and today’s decision allows certain patients to benefit from the drug sooner in their treatment pathway.

Matthew Hickling, medical director of Ipsen UK & Ireland, said: “This decision is very positive news for advanced renal cell carcinoma patients that don’t have time to wait and can now access cabozantinib earlier in their treatment pathway.”

Kidney cancer is the seventh most common cancer in the UK and is responsible for around 12,600 new cases every year.

The ‘challenging illness’ is on the rise in the country too. Over the last decade alone there was a 47% increase of kidney cancer incidences in the UK, and that percentage is expected to climb 26% by 2035.

Hickling added: “This reimbursement decision reflects the importance of our partnership with NICE who recognise that there are still limited treatment options available for people who have advanced RCC, a cancer which still has such a poor prognosis with a high unmet need.”

NICE’s recommendation was based on results from the phase II CABOSUN study, which showed that Cabometyx met the primary endpoint of demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS).

When compared to Pfizer’s Sutent, the current standard of care, those on Cabometyx showed a median PFS of 8.2 months versus 5.6 months.

Reaching a secondary endpoint, the drug had a median overall survival (OS) of 26.6 months compared with 21.2 months for Sutent.

The approval is a reverse on NICE’s preliminary decision to reject first-line use of the drug.

Despite recognising its clinical benefits, in June this year NICE said overall survival data was unclear, adding that the cost-effectiveness estimates were higher than what would normally be considered acceptable for routine NHS use.

Article by
Gemma Jones

24th August 2018

From: Regulatory

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