Ipsen/Exelixis' drug approved in EU for kidney cancer

Ipsen/Exelixis' Cabometyx  once-daily tablet has been approved in the EU in patients with advanced renal cell carcinoma following prior VEGF-targeted therapy.

Following approval by the European Commission, Cabometyx (cabozantinib) will be the only licensed treatment to show significantly improved overall survival, progression-free survival and objective response rate compared with Novartis' Afinitor (everolimus).

The commission granted a marketing authorisation for Cabometyx, originally developed by Exelixis, following an accelerated review reserved for medical products expected to be of major public interest.

The licence is based on results of the METEOR trial, involving 658 patients across 173 centres in 26 countries.

Already approved in the US in this indication earlier this year, Cabometyx is expected to take sales away from Afinitor.

With some predicting sales north of a billion dollars, Cabometyx is expected to be a major drug for the companies.

The drug is also being developed in untreated advanced renal cell carcinoma, although it initially failed to produce convincing results in prostate cancer. It has also been approved in medullary thyroid cancer in the US and EU.

Exelixis and Ipsen in February announced an exclusive licensing agreement for the commercialisation and further development of cabozantinib indications outside of the United States, Canada and Japan.

Cabometyx works by targeting cancer receptors associated with resistance and relapse – MET, AXL, RET and three VEGF receptors, preventing formation of blood vessels that feed the cancer cells.

By starving the cells of oxygen, Cabometyx helps prevent them from migrating around the body.