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Ipsen receives European first-line approval for Cabometyx

Published on 17/05/18 at 10:50am

Ipsen has revealed that it has received approval for the use of Cabometyx for first-line use in patients with advanced renal cell carcinoma (RCC).

The approval builds on the second line approval it had previously received in 2016, although negotiations with numerous European countries over the price of medicine have delayed access for many nations until recently.

NICE gave approval for the use of the treatment in July 2017, close to a year after its EC approval.

Though sales so far have not been blistering, recording European sales of only £25 million in the first quarter, it is expected that this first-line approval and with numerous funding agreements falling into place with payers that the drug sales will grow quickly.

Part of the reason for this is the advantage it holds over a main competitor, in BMS’ Opdivo; Cabometyx is differentiated by being available in oral form, which makes it far more convenient than having to visit a hospital for IV infusion.

“Today’s EC approval is a step forward for advanced kidney cancer patients in Europe who will be able to access a new oral first-line treatment option that offers significant improvement over the standard of care”, said Harout Semerjian, Executive Vice President, Chief Commercial Officer, Ipsen.  “Ipsen remains committed to improving patients’ lives by continuing to develop new therapies and expanding the potential of Cabometyx across different indications.”

The approval is based on results from a Phase 3 trial that hit primary endpoint of extending progression-free survival (PFS). The data revealed that PFS was improved by 8.6 months, compared with 5.3 months of patients taking Pfizer’s Sutent. In terms of overall survival (OS), the company reported that it showed a favourable, though not statistically significant, trend – as OS with Cabometyx stood at 26.6 months against 21.2 months on Sutent.

In terms of further development, Ipsen is developing the treatment as an adjunct alongside immunotherapy.

Ben Hargreaves

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